Infusion Pump System with Contamination-Resistant Features

ABSTRACT

Some embodiments of an infusion pump system may include a construction that is resistant to external contaminants, such as precipitation, water splashes, sweat and the like. In particular embodiments, the infusion pump system can include a pump device that is removably attached to a controller device to provide an electrical connection therebetween. In such circumstances, the infusion pump system can be assembled as a sealed construction that protects the electrical connection between the pump device and the removable controller device.

TECHNICAL FIELD

This document relates to configurations of an infusion pump system, suchas a wearable infusion pump system for the delivery of medicine.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

SUMMARY

Some embodiments of an infusion pump system may include a constructionthat is resistant to external contaminants, such as precipitation, watersplashes, sweat, dirt, and the like. Such a construction can protectsensitive internal components of the pump system, thereby providing asafe and reliable infusion pump system that can be worn by the userduring normal daily activities. In particular embodiments, the infusionpump system can include a pump device that is removably attached to acontroller device to provide an electrical connection therebetween. Insuch circumstances, the infusion pump system can be assembled as asealed construction that protects the electrical connection between thepump device and the removable controller device.

Some embodiments of a wearable infusion pump system may include adisposable and non-reusable pump device having a drive system todispense medicine from the pump device. The pump device may include afirst electrical connector that is externally accessible. The wearableinfusion pump system may also include a reusable controller device thatis removably attachable to the disposable and non-reusable pump device.The controller device may include a second electrical connector that isengageable with the first connector to provide electrical communicationbetween control circuitry of the controller device and the drive systemof the pump device. The wearable infusion pump system may furtherinclude a water-resistant seal device arranged proximate to the firstand second electrical connectors when the controller device is removablyattached to the pump device.

A number of embodiments include a method of connecting components of aninfusion pump system. The method may include preparing a pump device foruse with a controller device. The pump device may include a drive systemto dispense medicine from the pump device. The controller device mayinclude control circuitry to communicate control signals to the drivesystem of the pump device. The method may also include removablyattaching the pump device with the controller device so that a firstelectrical connector of the pump device engages a second electricalconnector of the controller device. The method may further includecompressing a water-resistant seal device between the pump device andthe controller to resist migration of water toward the first and secondelectrical connectors.

Some embodiments of a contaminant-resistant infusion pump assembly mayinclude a pump device that has: a drive system to dispense a medicinefrom the pump device, a pump housing to enclose at least a portion ofthe drive system, and a first electrical connector that is externallyaccessible along the pump housing. The infusion pump assembly may alsoinclude a seal device attached to the pump housing proximate to thefirst electrical connector. The infusion pump assembly may furtherinclude a controller device removably attached to the pump device. Thecontroller device may have: a user interface having a display device andat least one button, control circuitry to communicate with the drivesystem of the pump device, a controller housing to enclose at least aportion of the control circuitry, and a second electrical connector isengaged with the first connector to provide electrical communicationbetween the control circuitry and the drive system. The seal device canbe arranged between a surface of the pump housing and an opposingsurface of the controller housing to resist migration of externalcontaminants toward the first and second electrical connectors.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of an infusion pumpsystem may include a configuration that resists migration of externalcontaminants, such as precipitation, water splashes, sweat and the like.This configuration may provide a safe and reliable infusion pump systemthat can be worn by the user during normal daily activities.

Second, some embodiments of the infusion pump system may include areusable controller device that is removably attachable to a disposablesingle-use pump device to provide an electrical connection therebetween.In these circumstances, the infusion pump system can include awater-resistant seal that protects the electrical connection between thepump device and the controller device. Accordingly, thecontaminant-resistant construction can protect sensitive internalcomponents of the pump system.

Third, the water-resistant seal that protects the electrical connectionbetween the disposable single-use pump device and the controller devicemay be provided on the housing of the pump device. Because thecontroller device can be reused with a series of successive pumpdevices, the infusion pump system is provided with a new seal to providethe electrical connection with each new pump device.

Fourth, some embodiments of the pump device may be attached to thecontroller device so that a user can readily monitor infusion pumpoperation by simply viewing the user interface connected to the pumpdevice. In these circumstances, the user may activate and control thepump device without the requirement of locating and operating a separatemonitoring module.

Fifth, some embodiments of the infusion pump system may be configured tobe portable, wearable, and (in some circumstances) concealable. Forexample, a user can conveniently wear the infusion pump system on theuser's skin under clothing or can carry the pump device in the user'spocket (or other portable location) while receiving the medicinedispensed from the pump device.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system in accordancewith some embodiments, in accordance with some embodiments.

FIG. 2 is a perspective view of the infusion pump system of FIG. 1 in anassembled state.

FIG. 3 is another perspective view of the infusion pump system of FIG.2.

FIG. 4 is a perspective view of the infusion pump system of FIG. 1 in adetached state.

FIG. 5 is another perspective view of the infusion pump system on FIG.4.

FIG. 6 is a perspective view of an infusion pump system, in accordancewith some embodiments.

FIG. 7 is a perspective view of the infusion pump system of FIG. 6 wornon clothing of a user.

FIG. 8 is a perspective view of an infusion pump system worn on skin ofa user, in accordance with particular embodiments.

FIG. 9 is a perspective view on an infusion pump system having anillumination instrument, in accordance with some embodiments.

FIG. 10 is a perspective view of an infusion pump system having anillumination instrument, in accordance with particular embodiments.

FIGS. 11-12 are perspective views of a pump device being detached from acontroller device, in accordance with some embodiments.

FIGS. 13-14 are perspective views of the pump device of FIGS. 11-12being discarded and the controller device of FIGS. 11-12 being reusedwith a new pump device.

FIGS. 15-16 are perspective views of the new pump device of FIG. 13being attached to the controller device of FIG. 13.

FIG. 17 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 18 is an exploded perspective view of a pump device for an infusionpump system, in accordance with some embodiments.

FIG. 19 is a perspective view of a portion of the pump device of FIG.18.

FIG. 20 is a top view of a portion of the pump device of FIG. 18.

FIG. 21 is an exploded perspective view of a medicine cartridge and aflexible piston rod, in accordance with some embodiments.

FIGS. 22-25 are perspective views of a portion of a drive system for thepump device of FIG. 18.

FIG. 26 is a perspective view of occlusion sensor circuitry from acontroller device arranged adjacent to a cap of a pump device, inaccordance with some embodiments.

FIG. 27 is a cross-sectional view of the cap device of FIG. 26.

FIGS. 28-29 are cross-sectional views of an occlusion sensor for use inan infusion pump system.

FIGS. 30-31 are cross-sectional views of the occlusion sensor of FIGS.28-29.

FIGS. 32-33 are diagrams of the occlusion sensor of FIGS. 30-31.

FIG. 34 is a cross-sectional view of an alternative embodiment of thecap device of FIG. 26.

FIGS. 35-36 are cross-sectional views of a portion of a fluid channelthrough the cap device of FIG. 34, in accordance with some embodiments.

FIGS. 37-38 are diagrams of an alternative embodiment of an occlusionsensor to be arranged adjacent to the cap device of FIG. 34.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1-3, an infusion pump system 10 can include a pumpdevice 100 and a controller device 200 that communicates with the pumpdevice 100. The pump device 100 includes a housing structure 110 thatdefines a cavity 116 in which a fluid cartridge 120 can be received. Thepump device 100 also includes a cap device 130 to retain the fluidcartridge 120 in the cavity 116 of the housing structure 110. The pumpdevice 100 includes a drive system (described in more detail below) thatadvances a plunger 125 in the fluid cartridge 120 so as to dispensefluid therefrom. The controller device 200 communicates with the pumpdevice 100 to control the operation of the drive system. When thecontroller device 200, the pump device 100 (including the cap device130), and the fluid cartridge 120 are assembled together, the user can(in some embodiments) conveniently wear the infusion pump system 10 onthe user's skin under clothing or in the user's pocket while receivingthe fluid dispensed from the pump device 100.

The controller device 200 may be configured as a reusable component thatprovides electronics and a user interface to control the operation ofthe pump device 100. In such circumstances, the pump device 100 can be adisposable component that is disposed of after a single use. Forexample, the pump device 100 can be a “one time use” component that isthrown away after the fluid cartridge 120 therein is exhausted.Thereafter, the user can removably attach a new pump device 100 to thereusable controller device 200 for the dispensation of fluid from a newfluid cartridge 120. Accordingly, the user is permitted to reuse thecontroller device 200 (which may include complex or valuableelectronics) while disposing of the relatively low-cost pump device 100after each use. Such a pump system 10 can provide enhanced user safetyas a new pump device 100 (and drive system therein) is employed witheach new fluid cartridge 120.

Briefly, in use, the pump device 100 is configured to removably attachto the controller device 200 in a manner that provides a secure fitting,an overall compact size, and a reliable electrical connection that isresistant to water migration. For example, as described in more detailbelow in connection with FIGS. 1-5, the controller device 200 includes ahousing 210 having a number of features that mate with complementaryfeatures of the pump housing 10. In such circumstances, the controllerdevice 200 can removably attach with the pump device 100 in a generallyside-by-side configuration while not fully surrounding the pump housing110. Accordingly, the pump device 100 and the controller device 200 canbe separate components that fit together, but the overall size of thecombined assembly is reduced because there is no requirement for onecomponent (e.g., the controller device) to completely surround orenvelop the second component (e.g., the pump device). The compact sizepermits the infusion pump system 10 to be discrete and portable (asdescribed below in connection with FIGS. 6-8). Moreover, at least one ofthe pump device 100 or the controller device 200 may include a releasemember that facilitates an easy-to-use detachment and replacementprocess. For example, as described in more detail below in connectionwith FIGS. 11-16, an exhausted pump device 100 may be a “one time use”component that is discarded after being used, and a new pump device 100′(having a new medicine cartridge 120′) can thereafter be attached to thecontroller device 200.

Moreover, the pump device 100 and the controller device 200 can bemounted to one another so that the assembled system 10 is resistant tomigration of external contaminants (e.g., water from precipitation orsplashing, sweat, and the like) both into the pump housing structure 110and the controller housing structure 210. In particular, the infusionpump system 10 may include one or more seals that are arranged to hindermigration of external contaminants into the cavity of the pump device100 (e.g., to protect the insulin container 120 and the drive systemduring operation). Also, the infusion pump system may include one ormore gaskets arranged proximate to the electrical connection location(between the pump device 100 and the controller device 200) to protectthe electrical connection from migration of external contaminants. Thus,in some embodiments, the infusion pump system 10 can be assembled into awater resistant configuration that protects sensitive components fromwater migration (e.g., if the user encounters water while wearing thepump system 10).

In addition or in the alternative, the controller device 200 can beequipped with an illumination instrument 230 that provides the user withan opportunity to illuminate and inspect a targeted location. Forexample, as described in more detail below in connection with FIGS.9-10, the light emitting device 230 can be directed at the infusion siteon the user's skin to verify that the infusion set is properly embedded,or the light emitting device 230 can be directed at the pump device 100to illuminate the cavity 116 or other areas.

Furthermore, in use, the controller device 200 can include a sensorconfiguration that detects occlusions in the fluid flow path extendingto the user. For example, the controller device 200 may include anoptical sensor system 250 that detects the amount of light reflectedfrom a portion of the cap device 130. As described in more detail belowin connection with FIGS. 26-38, the amount of light reflected from thecap device 130 may change if an occlusion occurs to cause an increase inthe fluid pressure. For instance, some embodiments of the optical sensorsystem 250 may operate using the principle of total internal reflection.The optical sensor system 250 may include a number of components thatare housed in the controller device 200. In one example, the lightemitter and light sensor may be arranged on a sensor circuit in thecontroller device 200, thereby permitting these components to be reusedalong with the controller device (while the relatively low costcomponents in the pump device 100 are discarded after the “one time use”of the pump device 100).

Referring again to FIGS. 1-3, in this embodiment, the pump system 10 isa medical infusion pump system that is configured to controllablydispense a medicine from the cartridge 120. As such, the fluid cartridge120 may contain a medicine 126 (FIG. 1) to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: pain relief drugs, hormonetherapy, blood pressure treatments, anti-emetics, osteoporosistreatments, or other injectable medicines. The fluid cartridge 120 mayhave other configurations. For example, the fluid cartridge may comprisea reservoir that is integral with the pump housing structure 110 (e.g.,the fluid cartridge can be defined by one or more walls of the pumphousing structure 110 that surround a plunger to define a reservoir inwhich the medicine is injected or otherwise received).

In some embodiments, the pump device 100 may include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 1, the pump housing structure 110 may includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. In this embodiment, thepump housing structure 110 includes a pair of opposing retainer wings119 (only one is shown in the view in FIG. 1) that flex toward the innersurface of the cavity 116 during insertion of the medicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings 119 are biased to flex outward (toward the center of thecavity 116) so that the retainer wings 119 engage a neck portion 129 ofthe medicine cartridge 120. This engagement with the retainer wings 119and the neck portion 129 hinder any attempts to remove the medicinecartridge 120 away from the pump device 100.

Such a configuration may facilitate the “one-time-use” feature of thepump device 100. Because the retainer wings 119 interfere with attemptsto remove the medicine cartridge 120 from the pump device 100, the pumpdevice 100 will be discarded along with the medicine cartridge 120 afterthe medicine cartridge 120 is emptied, expired, or otherwise exhausted.The retainer wings 119 may serve to hinder attempts to remove theexhausted medicine cartridge 120 and to insert a new medicine cartridge120 into the previously used pump device 100. Accordingly, the pumpdevice 100 may operate in a tamper-resistant and safe manner because thepump device 100 can be designed with predetermined life expectancy(e.g., the “one-time-use” feature in which the pump device is discardedafter the medicine cartridge 120 is emptied, expired, or otherwiseexhausted).

Still referring to FIGS. 1-3, the cap device 130 can be joined with thepump device 100 after the medicine cartridge is inserted in the cavity116. In this embodiment, the cap device 130 is multifunctional in thatit performs a number of functions for the pump device operation. Forexample, attachment of the cap device 130 may cause one or more of thefollowing preparatory functions: forcing the plunger 125 (FIG. 1) of thefluid cartridge 120 to engage with the piston rod (not shown in FIGS.1-3, refer for example to FIG. 19), piercing a septum 121 of the fluidcartridge 120 to provide a flow path for the fluid (refer for example toFIG. 27), and priming the fluid cartridge 120 with a “break away” forceto initiate movement of the plunger 125 in the fluid cartridge 120. Inaddition or in the alternative, attachment of the cap device 130 mayalso cause one or more of the following safety related functions:aligning an occlusion sensor 250 with the a portion of the fluid flowpath (described in connection with FIGS. 26-38), sealing the pumphousing 110 (e.g., using a polymeric o-ring seal 131 or the like) toresist migration of external contaminants into the cavity 116, andceasing or preventing the dispensation of fluid if the cap device 130 isimproperly engaged with the pump housing 110. In other embodiments, thecap device 130 may supplement or replace the previously describedretainer wings 119 by locking into position after joining with the pumphousing 110, thereby hindering removal of the fluid cartridge 120 in thepump housing 110.

The cap device 130 can include one or more alignment tabs 132 thatoperate to ensure that the cap device 130 is joined with the pumphousing 110 in a selected orientation. For example, as shown in FIGS.2-3, the cap device 130 may include an output port 139 that connectswith tubing (e.g., FIG. 6) for dispensation of the medicine to the user.The output port 139 may have an angled orientation such that a portionof the tubing extends transversely to the central axis of the cartridge120 and cap device 130. The alignment tabs 132 arranged on the body ofthe cap device 130 can align with adjacent surfaces of the controllerhousing 210 to provide the selected orientation of the output portduring operation. If, for example, the cap device 130 were joined withthe pump housing 100 in an orientation that is 180-degrees off from theselected orientation, the alignment tabs 132 would receive interferencefrom the barrel channel 211 of the controller housing 210. As such, theuser would be unable to attach the pump device 100 to the controller200, thereby indicating to the user that the cap device 130 must bereoriented to the selected position.

Still referring to FIGS. 1-3, the controller device 200 may be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. Such amechanical mounting can form an electrical connection between theremovable controller device 200 and the pump device 100. For example,the controller device 200 may be in electrical communication with aportion of a drive system (not shown in FIGS. 1-3) of the pump device100. As described in more detail below, the pump device 100 includes adrive system that causes controlled dispensation of the medicine orother fluid from the cartridge 120. In some embodiments, the drivesystem incrementally advances a piston rod (not shown in FIGS. 1-3)longitudinally into the cartridge 120 so that the fluid is forced out ofan output end 122. A septum 121 (FIG. 1) at the output end 122 of thefluid cartridge 120 can be pierced to permit fluid outflow when the capdevice 130 is connected to the pump housing structure 110 (described inmore detail below). Thus, when the pump device 100 and the controllerdevice 200 are attached and thereby electrically connected, thecontroller device 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

In some embodiments, the controller device is configured to removablyattach to the pump device 100 in a side-by-side arrangement. As such,the controller device 200 can be electrically connected with the pumpdevice 100 while the controller device 200 remains outside of the pumphousing 110 (and, likewise, the pump device 100 remains outside of thecontroller housing 210). Accordingly, the pump device 100 and thecontroller device 200 can be separate components that fit together, butthe overall size of the combined assembly is reduced because there is norequirement for one component (e.g., the controller device) tocompletely surround or envelop the second component (e.g., the pumpdevice). The compact size permits the infusion pump system 10 to bediscrete and portable when the pump device 100 is attached with thecontroller device 200 (as shown in FIGS. 2-3). In this embodiment, thecontroller device 200 includes a controller housing structure 210 havinga number of features (e.g., a barrel channel 211, a rail 212, adepression 213, and a guide channel 214 a-b that is segmented by arelease latch 215) that are configured to mate with complementaryfeatures (e.g., a barrel 111, a slider channel 112, an mating extension113, and a segmented guide rail 114 a-b) of the pump housing structure110 so as to form a releasable mechanical connection (as shown, forexample, in FIGS. 1 and 4-5). Such mating features of the pump housingstructure 110 and the controller housing structure 210 can provide asecure connection in the previously described side-by-side arrangement.It should be understood that, in other embodiments, other features orconnector devices can be used to facilitate the side-by-side mountingarrangement. These other features or connector devices may include, forexample, magnetic attachment devices, mating tongues and grooves, or thelike.

As shown in FIG. 1, the pump device 100 may include an electricalconnector 118 (e.g., having conductive pads, pins, and the like) thatare exposed to the controller device 200 and that mate with acomplementary electrical connector (refer to connector 218 in FIG. 4) onthe adjacent face of the controller device 200. The electricalconnectors 118 and 218 provide the electrical communication between thecontrol circuitry (refer, for example, to FIG. 17) housed in thecontroller device 200 and at least a portion of the drive system orother components of the pump device 100. For example, in someembodiments, the electrical connectors 118 and 218 permit thetransmission of electrical control signals to the pump device 100 andthe reception of feedback signals (e.g., sensor signals) from particularcomponents within the pump device 100. Furthermore, as described in moredetail below, the infusion pump system 10 may include a gasket 140 thatprovides a seal that is resistant to migration of external contaminantswhen the pump device 100 is attached to the controller device 200. Thus,in some embodiments, the infusion pump system 10 can be assembled into awater resistant configuration that protects the electricalinterconnection from water migration (e.g., if the user encounters waterwhile carrying the pump system 10).

Still referring to FIGS. 1-3, the controller device 200 includes a userinterface 220 that permits a user to monitor the operation of the pumpdevice 100. In some embodiments, the user interface 220 includes adisplay 222 and one or more user-selectable buttons (e.g., four buttons224 a, 224 b, 224 c, and 224 d in this embodiment). The display 222 mayinclude an active area in which numerals, text, symbols, images, or acombination thereof can be displayed (refer, for example, to FIG. 2).For example, the display 222 may be used to communicate a number ofsettings or menu options for the infusion pump system 10. In thisembodiment, the user may press one or more of the buttons 224 a, 224 b,224 c, and 224 d to shuffle through a number of menus or program screensthat show particular settings and data (e.g., review data that shows themedicine dispensing rate, the total amount of medicine dispensed in agiven time period, the amount of medicine scheduled to be dispensed at aparticular time or date, the approximate amount of medicine remaining inthe cartridge 120, or the like). In some embodiments, the user canadjust the settings or otherwise program the controller device 200 bypressing one or more buttons 224 a, 224 b, 224 c, and 224 d of the userinterface 220. For example, in embodiments of the infusion pump system10 configured to dispense insulin, the user may press one or more of thebuttons 224 a, 224 b, 224 c, and 224 d to change the dispensation rateof insulin or to request that a bolus of insulin be dispensedimmediately or at a scheduled, later time. Also, as described below inconnection with FIGS. 9-10, the user can activate the illuminationinstrument 230 on the controller device 200 by pressing one or morebuttons 224 a, 224 b, 224 c, and 224 d of the user interface 220.

The display 222 of the user interface 220 may be configured to displayquick reference information when no buttons 224 a, 224 b, 224 c, and 224d have been pressed. For example, as shown in FIG. 2, the active area ofthe display 222 can display the time and the date for a period of timeafter no button 224 a, 224 b, 224 c, and 224 d has been actuated (e.g.,five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like).Thereafter, the display 222 may enter sleep mode in which the activearea is blank, thereby conserving battery power. In addition or in thealternative, the active area can display particular device settings,such as the current dispensation rate or the total medicine dispensed,for a period of time after no button 224 a, 224 b, 224 c, or 224 d hasbeen actuated (e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5minutes, or the like). Again, thereafter the display 222 may enter sleepmode to conserve battery power. In certain embodiments, the display 222can dim after a first period of time in which no button 224 a, 224 b,224 c, or 224 d has been actuated (e.g., after 15 seconds or the like),and then the display 22 can enter sleep mode and become blank after asecond period of time in which no button 224 a, 224 b, 224 c, or 224 dhas been actuated (e.g., after 30 seconds or the like). Thus, thedimming of the display device 222 can alert a user viewing the displaydevice 222 when the active area 223 of the display device will soonbecome blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the user interface 220 of thecontroller device 200 connected to the pump device 100. Such monitoringcapabilities may provide comfort to a user who may have urgent questionsabout the current operation of the pump device 100 (e.g., the user maybe unable to receive immediate answers if wearing an infusion pumpdevice having no user interface attached thereto).

Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200, which is removably attachedto the pump device 100, without the requirement of locating andoperating a separate monitoring module.

In other embodiments, the user interface 200 is not limited to thedisplay and buttons depicted in FIGS. 1-3. For example, in someembodiments, the user interface 220 may include only one button or mayinclude a greater numbers of buttons, such as two buttons three buttons,four buttons, five buttons, or more. In another example, the userinterface 220 of the controller device 200 may include a touch screen sothat a user may select buttons defined by the active area of the touchscreen display. Alternatively, the user interface 220 may comprise audioinputs or outputs so that a user can monitor the operation of the pumpdevice 100.

Referring now to FIGS. 4-5, when the infusion pump system 10 operates,the controller device 200 is removably attached to the pump device 100in a side-by-side arrangement. For example, the pump device 100 may bemoved in a longitudinal direction (e.g., refer to direction 219 in FIG.15) toward the controller device 200 until the complementary featuresconnect and secure the separate components in the side-by-sidearrangement. In these circumstances, the pump device 100 and thecontroller device 200 can be separate components that fit together, butthe overall size of the combined assembly is reduced because there is norequirement for one component (e.g., the controller device or pumpdevice) to surround or envelop the second component (e.g., the pumpdevice or controller device). Moreover, in some embodiments, the pumpdevice 100 and controller device 200 can be readily attached togetherwith a “one-movement” process that is convenient to the user (describedin more detail below).

In this embodiment, the controller device 200 includes a controllerhousing structure 210 having a number of features that are configured tomate with complementary features of the pump housing structure 110 so asto form a releasable mechanical connection. For example, the pumphousing structure 110 may include a barrel 111 that mates with acomplementary barrel channel 211 of the controller housing 210. Also,the pump housing 110 includes slider channel 112 that slidably engages acomplementary rail 212 defined by the controller housing 210. The sliderchannel 112 can guide the relative motion between the pump device 100and the controller device 200 in the longitudinal direction during theattachment process. Similarly, the pump housing 110 may include asegmented rail 114 a-b (FIG. 1) that mates with a guide channel 214 a-bto direct the relative longitudinal motion between the pump device 100and the controller device 200. As described in more detail below, thesegmented rails 114 a-b may interact with the release member 215 so asto releasably secure the pump device 100 into assembly with thecontroller device 200. In addition, the pump housing 110 may include anextension 113 (FIG. 1) that mates with a depression 213 (FIG. 5) in thecontroller housing 210 when the pump device 100 is fully attached to thecontroller device 200.

Still referring to FIGS. 4-5, when the pump device 100 is advanced inthe longitudinal direction toward the controller device 200 as guided bythe slider channel 112 and the segmented rails 114 a-b, the electricalconnector 118 (FIG. 5) of the pump device 100 is directed towardengagement with the mating connector 218 (FIG. 4) of the controllerdevice 200. As the connectors 118 and 218 join together to form theelectrical connection, the release member 215 is shifted to a positionbetween the segmented rails 114 a-b so as to prevent withdrawal of theconnection. Also, when the connectors 118 and 218 are mated, theextension 113 and barrel 111 are mated with the corresponding depression213 and barrel channel 211 so as to resist relative rotational movementbetween the pump device 100 and the controller device 200. In thisembodiment, the physical attachment of the electrical connectors 118 and218 may also serve to resist relative rotational movement between thepump device 100 and the controller device 200. Furthermore, when theconnectors 118 and 218 are mated, the slide channel 112 is mated withthe corresponding rail 112 and barrel channel 211 so as to resistrelative side-to-side movement between the pump device 100 and thecontroller device 200.

Accordingly, the pump device 100 is configured to removably attach tothe controller device 200 in a manner that provides a secure fitting, anoverall compact size, and a reliable electrical connection. When thepump device 100 and the controller device 200 are arranged in thisside-by-side configuration, the controller device 200 can beelectrically connected with the pump device 100 while the controllerdevice 200 remains outside of the pump housing 110 (and, likewise, thepump device 100 remains outside of the controller housing 210). As such,the overall size of the assembled system 10 can be minimized, therebyproviding an infusion pump system 10 having a discrete size and enhancedportability.

Additionally, in some embodiments, the attachment of the pump device 100to the controller device 200 can be accomplished by a user with aconvenient “one-movement” process. For example, as previously described,the user can readily slide the pump device 100 and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. As described in more detail below in connection with FIGS.11-16, the release member 215 may be arranged so as to automaticallyadjust to a locked position when the pump device 100 is advanced intoengagement with the controller device 200. Thus, the infusion pumpsystem 10 permits users to readily join the pump device 100 and thecontroller device 200 without compound or otherwise difficult handmovements—a feature that can be beneficial to child users or to elderlyusers.

It should be understood that, in other embodiments, other features orconnector devices can be used to facilitate the side-by-side mountingarrangement. These other features or connector devices may include, forexample, magnetic attachment device, mating tongues and grooves,mounting protrusions that friction fit into mating cavities, or thelike.

Still referring to FIGS. 4-5, the pump device 100 and the controllerdevice 200 can be attached in a manner that is resistant to migration ofexternal contaminants (e.g., water, dirt, and the like) both into thepump housing structure 110 and the controller housing structure 210. Forexample, when the pump device 100 is advanced in the longitudinaldirection toward the controller device 200 (as guided by the sliderchannel 112 and the segmented rails 114 a-b), the electrical connector118 (FIG. 5) of the pump device 100 is directed toward engagement withthe mating connector 218 (FIG. 4) of the controller device 200. When theconnectors 118 and 218 join together to form the electrical connection,the gasket 140 is compressed between the adjacent surfaces of the pumphousing 110 and the controller housing 210. The gasket 140 thereby formsa water-resistant seal between the ambient environment and the matedconnectors 118 and 218.

The gasket 140 may comprise a polymer foam material that is adhered to asurface of either the pump housing 110 or the controller housing 210(e.g., adhered to the pump housing 110 in this embodiment). The gasket140 may be die cut to a selected shape so as to include an aperture forthe electrical connection. Thus, in this embodiment, the gasket 140surrounds the electrical connection when the pump device 100 is securedto the controller device 200. The configuration provides protection fromwater migration to one or both of the electrical connectors 118 and 218.Accordingly, in particular circumstances, the infusion pump system 10can be assembled into a “water tight” configuration that protectssensitive internal components from water migration in the event that theuser encounters water while wearing the pump system 10. In one example,the gasket 140 may resist migration of water to the electricalconnectors 118 and 218 even when the system 10 is submerged underwater(e.g., in a pool, in a bath, or the like) for an extended period oftime, such as at least 10 minutes, at least 30 minutes, at least onehour, at least two hours, and preferably at least four hours.

As shown in FIG. 5, the gasket 140 is arranged to extend generallyperpendicular to the assembly motion when the pump device 100 is beingattached to the controller device. For example, the pump device 100 canbe attached to the controller device 200 by moving the pump device 100in the longitudinal direction (e.g., refer to direction 219 in FIG. 15).The gasket 140 includes a major interface surface extends in a generallylateral direction that is perpendicular to the longitudinal assemblymotion. Because the gasket 140 extends in a direction (e.g., the lateraldirection in this embodiments) that is generally perpendicular to theattachment direction (the longitudinal direction in this embodiment),the gasket 140 can be sufficiently compressed to form a seal when theuser performs the “one-movement” process to attach the pump device 100and the controller device 200.

In addition, other paths for migration of external contaminants into theassembled pump system 10 may be sealed. For example, the infusion pumpsystem 10 may include one or more seals that are arranged to hindermigration of external contaminants between the cap device 130 and thepump housing 110 into the cavity 116 of the pump device 100. In thisembodiment, the seal 131 arranged between the cap device 130 and thebarrel 111 can provide an effective water-resistant seal against watermigration into the cavity. As such, the medicine cartridge 120 and pumpdrive system (not shown in FIGS. 4-5) can be protected during operation.

Still referring to FIGS. 4-5, some embodiments of the infusion pumpsystem 10 may employ a power source arranged in pump device 100 or thecontroller device 200 that draws upon surrounding air for optimumoperation. Because the controller device 200 and the pump device 100 maybe sealed to resist water migration during normal usage, awater-resistant vent instrument 145 may be used to provide the air tothe power source without permitting migration of water therethrough. Forexample, in this embodiment, the pump device 100 may house a powersource 345 in the form of a zinc-air cell battery (refer to FIG. 18),which draws upon the surrounding air during operation. When the pumpdevice 100 is in use, the pump housing 110 is preferably sealed toprotect the internal drive system and medicine cartridge from watermigration. As such, the pump housing 110 may include a water-resistantvent instrument 145 disposed proximate to the zinc-air cell battery 345so that some air may pass through the vent 145 and toward the battery.The water-resistant vent instrument 145 may include one or more layersof a material that is permeable to air and resistant to passage ofliquids such as water. For example, the water-resistant vent instrument145 may include one or more layers of a GORE-TEX material to resist themigration of water into the pump device while permitting the passage ofair toward the battery.

Accordingly, the pump device 100 and the controller device 200 can bemounted to one another so that the assembled system 10 is resistant towater migration both into the pump housing structure 110 and thecontroller housing structure 210. Such a configuration may also providewater-resistant protection for the electrical connection between thepump device 100 and the controller 200. Thus, the sensitive internalcomponents in the controller device 200 and the pump device 100 can bereliably protected from water migration if the user encounters water(e.g., rain, incidental splashing, and the like) while using the pumpsystem 10.

Referring to FIGS. 6-8, the infusion pump system 10 may be configured tobe portable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump system 10 on the user's skin (e.g.,skin adhesive) underneath the user's clothing or carry the pump device100 in the user's pocket (or other portable location) while receivingthe medicine dispensed from the pump device 100. As described below inconnection with FIGS. 18-25, the drive system of the pump device 100 maybe arranged in a compact manner so that the pump device 100 has areduced length. For example, in the circumstances in which the medicinecartridge 120 has a length of about 6 cm to about 7 cm (about 6.4 cm inone embodiment), the overall length of the pump housing structure 110(which contains medicine cartridge and the drive system) can be about 7cm to about 10 cm and about 7 cm to about 9 cm (about 8.3 cm or less inone embodiment). In addition, the pump housing structure 110 may have anoverall height of about 2 cm to about 4 cm (about 3.1 cm or less in oneembodiment) and an overall thickness of about 8 mm to about 20 mm (about17.5 mm or less in one embodiment). In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump system 10 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 7 cm to about 10 cm (about 9.3cm or less in one embodiment), an overall height of about 2 cm to about5 cm (about 4.2 cm or less in one embodiment), and an overall thicknessof about 8 mm to about 20 mm (about 17.5 mm or less in one embodiment).

The pump system 10 is shown in FIG. 6 as being held in a user's hand 5so as to illustrate an exemplary size of the system 10 in accordancewith some embodiments. This embodiment of the infusion pump system 10 iscompact so that the user can wear the portable infusion pump system 10(e.g., in the user's pocket, connected to a belt clip, adhered to theuser's skin, or the like) without the need for carrying and operating aseparate module. In such embodiments, the cap device 130 of the pumpdevice 100 may be configured to mate with an infusion set 146. Ingeneral, the infusion set 146 is tubing system that connects theinfusion pump system 10 to the tissue or vasculature of the user (e.g.,to deliver medicine into the tissue or vasculature under the user'sskin). The infusion set 146 may include a flexible tube 147 that extendsfrom the pump device 100 to a subcutaneous cannula 149 retained by askin adhesive patch 148 that secures the subcutaneous cannula 149 to theinfusion site. The skin adhesive patch 148 can retain the infusioncannula 149 in fluid communication with the tissue or vasculature of thepatient so that the medicine dispensed through the tube 147 passesthrough the cannula 149 and into the user's body. The cap device 130 mayprovide fluid communication between the output end 122 (FIG. 1) of themedicine cartridge 120 and the tube 147 of the infusion set 146. Forexample, the tube 147 may be directly connected to the output port 139(FIG. 1) of the cap device 130. In another example, the infusion set 146may include a connector (e.g., a Leur connector or the like) attached tothe tube 147, and the connector can then mate with the cap device 130 toprovide the fluid communication to the tube 147. In these examples, theuser can carry the portable infusion pump system 10 (e.g., in the user'spocket, connected to a belt clip, adhered to the user's skin, or thelike) while the tube 147 extends to the location in which the skin ispenetrated for infusion. If the user desires to monitor the operation ofthe pump device 100 or to adjust the settings of the infusion pumpsystem 10, the user can readily access the user interface 220 of thecontroller device 200 without the need for carrying and operating aseparate module (refer for example to FIG. 6).

Referring to FIG. 7, in some embodiments, the infusion pump system 10 ispocket-sized so that the pump device 100 and controller device 200 canbe worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the system that comfortably fits intoa user's pocket 6. The user can carry the portable infusion pump system10 and use the tube 147 of the infusion set 146 extends to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump system 10 in a more discretemanner. Accordingly, the user may pass the tube 147 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 148 is positioned. As such, the pump system 10 can be used todelivery medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner.

Referring to FIG. 8, in other embodiments, the infusion pump system 10may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface 102 (FIG. 3) of the pump device 100 may includea skin adhesive patch so that the pump device 100 is physically adheredto the skin of the user at a particular location. In these embodiments,the cap device 130 may have a configuration in which medicine passesdirectly from the cap device 130 into an infusion cannula 149 that ispenetrated into the user's skin. In one example, the fluid output port139 through the cap device 130 can include a curve or a 90° corner sothat the medicine flow path extends longitudinally out of the medicinecartridge and thereafter laterally toward the patient's skin 7. Again,if the user desires to monitor the operation of the pump device 100 orto adjust the settings of the infusion pump system 10, the user canreadily access the user interface 220 of the controller device 200without the need for carrying and operating a second, separate device.For example, the user may look toward the pump device 100 to view theuser interface 220 of the controller device 200 that is removablyattached thereto. In another example, the user can temporarily detachthe controller device 200 (while the pump device 100 remains adhered tothe skin 7) so as to view and interact with the user interface 220.

Referring now to FIGS. 9-10, the infusion pump system 10 can include anillumination instrument 230 that provides the user with an opportunityto illuminate and inspect a targeted location. The illuminationinstrument 230 can be useful in situations where the ambient lighting isinsufficient for the user's inspection needs (e.g., during the night,during presentation or movie in which the lighting is low, or the like).The illumination instrument 230 can be arranged on the pump device 100,the controller device 200, or both. In this embodiment, the illuminationinstrument is arranged on the controller device 200. In suchcircumstances, the illumination instrument 230 can be directed at theinfusion site on the user's skin 8 to verify that the infusion setcannula 149 is properly embedded (refer, for example, to FIG. 9). Inanother example, the illumination instrument 230 can be directed at thepump device 100 to illuminate some portion of the pump device 100, suchas the cavity 116 in which the medicine cartridge 120 is received (referto FIG. 10).

During the operation of the infusion pump system 10, the user may beinstructed to periodically assess the condition of the connection of theinfusion set 146 into the user's body. This assessment can includevisually inspecting the adhesive pad 148 that secures the set to thebody and the cannula 149 that passes through the skin 8 to provideaccess for the medicine to enter the tissue or vasculature. In somecases, this inspection reveals that a new infusion set 146 is needed,and the user can thereafter change the infusion set 146 by attaching anew infusion set 146 to the user's skin 8 and the to the pump device100. Changing the infusion set 146 can be a detailed process thatrequires the user to visualize the infusion site along the skin 8 aswell as the tip of the infusion cannula 149 prior to insertion (e.g., toverify proper priming or filling of the infusion set tubing 147).

Also during operation of the infusion pump system 10, the user mayencounter a need to visually inspect one or more or components of thepump device 100. For example, the user may visually inspect the medicinecartridge 120 in the cavity 116 of the pump housing 110 to verify thefluid level in the medicine cartridge 120. Although the controllerdevice 200 can include sensors and software to track medicine usage andprovide an estimate of the remaining fluid volume, visual confirmationof the fluid level can be comforting to many users. If the visualinspection of the cavity 116 reveals that the medicine cartridge 120 hasa low fluid level or is broken, the user can employ a new pump device100′ and a new medicine cartridge 120′ as described below in connectionwith FIGS. 11-16.

As shown in FIGS. 9-10, the infusion pump system 10 can be equipped withthe illumination instrument 230 to conveniently aid in visual inspectionprocesses. For example, visual inspection and possible change of theinfusion set 146 may be required in less than optimal conditions,including low-light conditions. Likewise, visual inspection of the pumphousing cavity 116 (and the medicine cartridge 120 therein) may berequired in low-light conditions. The user interface 220 of thecontroller device 200 can include an illuminated display screen 222 tofacilitate the user's view of the display screen 22, but theillumination instrument 230 provides a dedicated light source forilluminating targeted sites external to the controller device 200 (e.g.,the skin 8, the infusion set 146, or the like).

The illumination instrument 230 can include one or more user triggeredlight sources that are positioned to direct illumination at targetedobjects outside of the pump system 10 or at components of the pumpdevice 100. In the embodiments depicted in FIGS. 9-10, the light sourceis arranged on the controller device 200. Such an arrangement providesclose proximity to the control circuitry 240 housed in the controllerdevice 200. In other embodiments, could be arranged on the pump device100 or on both the controller device 200 and the pump device 100.

Still referring to FIGS. 9-10, the illumination instrument 230 mayinclude a light source in the form of an LED device 232 (FIG. 17) thatis electrically connected to the control circuitry 240 (FIG. 17) in thecontroller housing 210. The light transmitted from the LED device 232may be directed through a light guide 234 (FIGS. 17 and 26) extending tothe controller housing 210 so that the light exits the light guide 234and illuminates the targeted object. In some circumstances, the lightguide 234 may operate as a light transmissive cover that permits lightto pass out of the controller device 200 while sealing out water orother contaminants. Such a construction, for example, may provide anillumination instrument 230 that emits an inspection light even whensubmerged underwater for a particular period of time. As shown in FIGS.9-10, the light from the illumination instrument 230 can be emitted froma side of the controller device 200 that is different from the side onwhich the user interface 220 is exposed. In this example, the light fromthe illumination instrument 230 exits from the light guide 234 toward atargeted site while the display 222 and buttons 224 a-d face a differentdirection. Thus, the illumination instrument 230 can direct aninspection light toward a targeted site while the user interface 220remains in a viewable position for the user.

In this embodiment, the illumination instrument 230 emits a beam oflight (e.g., a generally cylindrical or conical beam) that provides anintensity sufficient for visually inspecting external sites. Forexample, the light transmitted from the LED device 232 may be directedthrough a plastic light guide 234 to provide a beam of light having anillumination intensity that is sufficient to noticeably illuminate aspecific area (e.g., a circular area having a diameter of about 10inches) around a targeted site from more than six inches away, from morethat twelve inches away, and preferably from more than eighteen inchesaway.

The user may, for example, actuate one or more buttons 224 a-d of theuser interface 220 to activate the illumination instrument 230. Forexample, the illumination instrument 230 may be configured to activateand transmit light when the user presses a single button (e.g., activateimmediately when the single button is pressed or after the single buttonis pressed-and-held for a short period of time such as two seconds). Theillumination device 230 may remain activated while the selected buttonwas held down, and would thereafter shut off when the button is nolonger pressed. This press-and-hold activation sequence can conservebattery power as the light is emitted only as long as the user holds thebutton. In another example, the illumination instrument 230 may beconfigured to activate and transmit light when the user presses aspecified button sequence. The light would be emitted from theillumination instrument 230 while the user would have both handsavailable for the inspection process. To deactivate the illuminationinstrument 230 in this embodiment, the user may press another buttonsequence.

In other embodiments, the illumination instrument 230 can operate inconjunction with a timer that automatically deactivates the light sourceafter a predetermined period of time. The duration of the timer couldeither be preset at the factory or adjustable by the user (e.g., byselecting the particular menu settings with the user interface 220). Forexample, the control circuitry 240 (FIG. 17) may operate toautomatically shut off the illumination instrument 230 after apredetermined period of time, such as 5 seconds, 10 seconds, 20 seconds,30 seconds, or the like. Such a timer feature can reduce the requireduser input effort and can conserve battery power.

In some circumstances, the illumination instrument 230 may serve as anindicator to the user that a particular condition exists. For example,the illumination instrument 230 may be automatically activated by thecontroller device 200 to serve as an alarm that an error has occurred(e.g., a controller error, a drive system error, a flow path error, orthe like). In these circumstances, the illumination instrument 230 mayemit light in a steady state or in a pulsing state to notify the user ofthe detected error.

In addition, the illumination instrument 230 may be automaticallyactivated by the controller device during particular user interfaceactivities. For example, when the user indicates that a new infusion set146 is attached and should be “primed” to remove air gaps in the tubing147, the controller device 200 can automatically activate theillumination instrument 230. Such automatic activation may be useful forthe user in that the illumination device 230 can be readily directed toinspect the infusion set 146 without having to press a separate sequenceof buttons to activate the light source.

In some embodiments, the controller device may include features thatlimit when the illumination instrument can be activated. For example,the controller device 200 may include an ambient light sensor 226 (FIGS.9-10) to detect the light level available to the user. If the ambientlight level is higher than a particular threshold (e.g., if the user islocated in a lighted room or in daylight conditions), the illuminationinstrument 230 would not be automatically activated as previouslydescribed. As such, the battery power can be conserved by reducing theunnecessary illumination effects. In addition, the ambient light sensor226 may be used by the controller device 200 to conserve battery powerin other ways. For example, the lighting for display device 222 of theuser interface 220 can be automatically adjusted based on the lightingcondition detected by the ambient light sensor 226. The backlight forthe display device 222 may be automatically reduced by the controllerdevice 200 if the user is located in high-level lighting conditions(e.g., in a lighted room or in daylight conditions). Also, the backlightfor the display device 222 may be automatically increased by thecontroller device 200 if the user is located in low-level lightingconditions.

In another embodiment, the activation of the illumination instrument 230may be limited by the controller device 200 for reasons other thanambient lighting conditions. For example, the illumination instrument230 may be limited if the controller device 200 detects that theremaining capacity of the power source reaches below a threshold level.In such circumstances, the battery power can be automatically reservedfor use in operating the drive system to deliver medicine to the user.Alternatively, the illumination instrument 230 may be limited by thecontroller device 200 based on a power use profile. The power useprofile can provide an estimate of remaining battery life based on theuser's activity with the infusion pump system 10 (e.g., activations ofthe drive system to provide basal and bolus dispensations, historicalinteraction with the user interface 220, history of activating theillumination tool, and the like). Using this power use profile, thecontroller device 200 can estimate how long the remaining battery powerwill last in order to dispense the medicine remaining in the cartridge120. If the power use profile indicates that the remaining battery powermay be insufficient, particular features such as the illumination tool230 may be limited or shut off in order to conserve the remainingbattery power for activating drive system and indicating alarms. Inanother example, the controller device 200 may limit the number of usesof the illumination instrument 230 to a preset number of activations perday or per attachment of a new pump device 100. Again, providing a limiton the number of activations can conserve the battery power for otheroperations such as alarm indications and the drive system.

Referring now to FIGS. 11-16, the infusion pump system 10 can beoperated such that the pump device 100 is a disposable, non-reusablecomponent while the controller device 200 is a reusable component. Inthese circumstances, the pump device 100 may be configured as a“one-time-use” device that is discarded after the medicine cartridge isemptied, expired, or otherwise exhausted. Thus, in some embodiments, thepump device 100 may be designed to have an expected operational life ofabout 1 day to about 30 days, about 1 day to about 20 days, about 1 toabout 14 days, or about 1 day to about 7 days—depending on the volume ofmedicine in the cartridge 120, the dispensation patterns that areselected for the individual user, and other factors. For example, insome embodiments, the medicine cartridge 120 containing insulin may havean expected usage life about 7 days after the cartridge is removed froma refrigerated state and the septum 121 is punctured. In somecircumstances, the dispensation pattern selected by the user can causethe insulin to be emptied from the medicine cartridge 120 before the7-day period. If the insulin is not emptied from the medicine cartridge120 after the 7-day period, the remaining insulin may become expiredsometime thereafter. In either case, the pump device 100 and themedicine cartridge 120 therein can be discarded after exhaustion of themedicine cartridge 120 (e.g., after being emptied, expired, or otherwisenot available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 11-12, the pump device 100 can be readily removedfrom the controller device 200 when the medicine cartridge 120 isexhausted. As previously described, the medicine cartridge 120 isinserted into the cavity 116 (FIG. 1) of the pump housing 110 where itis retained by the cap device 130. In some embodiments, a portion of thepump housing 110 can comprise a transparent or translucent material sothat at least a portion of the medicine cartridge 120 is viewabletherethrough. For example, the user may want to visually inspect themedicine cartridge when the plunger 125 is approaching the output end122 of the medicine cartridge, thereby providing a visual indicationthat the medicine cartridge may be emptied in the near future. In thisembodiment, the barrel 111 of the pump housing 110 comprises a generallytransparent polymer material so that the user can view the medicinecartridge 120 to determine if the plunger 125 is nearing the end of itstravel length. Optionally, some embodiments of the pump device 100 mayinclude a label 117 a that is adhered around the barrel 111. The label117 a may provide a convenient location for basic user instructions,product identification information, and other information related to theinfusion pump system 10. To provide enhanced viewability of the medicinecartridge 120 through the label 117 a, the label 117 a may include awindow 117 b through which the user may visually inspect if the plunger125 is nearing the end of its travel length.

As shown in FIG. 11, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 11, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 (and through the window 117 b of the label117 a in this embodiment) to determine if the medicine cartridge 120 isalmost empty. When the user determines that a new medicine cartridge 120should be employed, the pump device 100 can be readily separated fromthe controller device 200 by actuating the release member 215. In thisembodiment, the release member 215 is a latch on the controller device200 that is biased toward a locking position to engage the pump device100. The latch may be arranged to engage one or more features on alateral side of the pump housing 110. As such, the user may actuate therelease member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 11) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 12, when the release member 215 is actuated and movedto a position away from the pump device 100, the segmented guide rail114 a-b is free to slide longitudinally in the guide channel 214 a-bwithout interference from the release member 215. Accordingly, the usercan move the pump device 100 in a longitudinal direction 217 away fromthe controller device 200. For example, the segmented guide rail 114 a-bmay slide along the guide channel 214 a-b, the extension 113 (FIG. 1)may be withdrawn from the mating depression 213 (FIG. 12), and theelectrical connector 118 can be separated from the mating connector 218.In these circumstances, the pump device 100 is physically andelectrically disconnected from the controller device 200 while the pumpdevice retains the exhausted medicine cartridge 120.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., move in the lateral direction 216 in theembodiment shown in FIG. 11). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 13-14, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 13) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 11-12 and 14), and thusthe new pump device 100′ can be readily attached to the controllerdevice 200 for controlled dispensation of medicine from the new medicinecartridge 120′. In some embodiments, the user may prepare the new pumpdevice 100 for use with the controller device 200. For example, the usermay insert the new medicine cartridge 120′ in the cavity 116 of the newpump device 100′ and then join the cap device 130 to the pump housing toretain the new medicine cartridge 120′ therein (refer, for example, toFIG. 1). Although the tubing 147 of the infusion set 146 is not shown inFIG. 13, it should be understood that the tubing 147 may be attached tothe cap device 130 prior to the cap device 130 being joined with thehousing 110. For example, a new infusion set 146 can be connected to thecap device 130 so that the tubing 147 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller 200) beforeattaching the infusion set patch to the user's skin. As shown in FIG.13, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111.

As shown in FIG. 14, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 11-12) may be discarded after a single use. In thesecircumstances, the pump device 100 may be configured as a disposable“one-time-use” device that is discarded by the user after the medicinecartridge 120 is emptied, is expired, has ended its useful life, or isotherwise exhausted. For example, the pump device 100 may be discardedinto a bin 20, which may include a trash bin or a bin specificallydesignated for discarded medical products. Thus, the user is permittedto dispose of the relatively low-cost pump device 100 after each usewhile reusing the controller device 200 (which may include complex orvaluable electronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 146 (not shown in FIG. 14, refer to FIG.8) that was used with the pump device 100 may be removed from the userand discarded into the bin 20 along with the pump device 100.Alternatively, the infusion set 146 can be disconnected from theprevious pump device 100 and attached to the new pump device 100′. Inthese circumstances, the user may detach the infusion set cannula andpatch from the skin so as to “re-prime” the tubing with medicine fromthe new pump device 100′ to remove air pockets from the tubing.Thereafter, the infusion set cannula and patch can be again secured tothe user's skin.

Referring to FIGS. 15-16, the new pump device 100′ can be removablyattached to the controller device 200 to assemble into the infusion pumpsystem 10 for delivery of medicine to the user. Before the pump device100 is electrically connected with the controller device 200, the usermay prepare the new pump device 100′ for use by pulling the removabletab 141 away from the pump housing 110. In this embodiment, the new pumpdevice 100′ includes the removable tab 141 to seal the battery in theunused pump device 100′ and thereby maintain the battery in a storagemode (refer, for example, to FIG. 14 in which the removable tab 141 isarranged to cover an internal face of the vent 115). As described inmore detail below, when the new pump device 100′ is prepared for usage,the removable tab 141 can be pulled away from the pump housing 110 (andaway from the battery therein), which switches the battery into anactivation mode. Thus, the shelf-life of the pump device 100′ (prior tousage with the controller device 200) may be extended by sealing thebattery in a storage mode because little, if any, energy is dissipatedfrom the battery when in the storage mode.

The new pump device 100′ can be connected to the controller device 200by advancing the new pump device 100′ in a longitudinal direction 219(FIG. 15) toward the controller device 200. When the pump device 100′ isadvanced in the longitudinal direction 219 toward the controller device200, the movement is guided by the slider channel 112 (FIGS. 4-5) andthe segmented rails 114 a-b. In particular, the slider channel 112 ofthe pump housing engages the rail 212 of the controller housing 210.Also, the front portion of the segmented rail 114 a slides into the rearportion of the guide channel 214 b. In this embodiment, the frontportion of the segmented rail 114 a includes a ramp surface 114 c (referalso to FIG. 1) that engages a complementary ramp surface 215 c (FIG. 4)of the release member 215 to thereby force the release member 215 awayfrom the guide channel 214 a-b during advancement of the pump device100′. The release member 215 is temporarily forced away from the guidechannel 214 a-b so that the front portion of the segmented rail 114 apasses over the release member 215, which enables the electricalconnector 118 of the pump device 100′ to engage with the matingconnector 218 of the controller device 200. As the connectors 118 and218 join together to form the electrical connection, the release member215 biased to return to its latched position and is shifted to aposition in the guide channel 214 a-b between the segmented rails 114a-b so as to prevent withdrawal of the pump device 100′.

Also, when the connectors 118 and 218 are mated, the extension 113(FIG. 1) and barrel 111 are mated with the corresponding depression 213and barrel channel 211 so as to resist relative rotational movementbetween the pump device 100 and the controller device 200. In thisembodiment, the physical attachment of electrical connectors 118 and 218may also serve to resist relative rotational movement between the pumpdevice 100 and the controller device 200. Furthermore, when theconnectors 118 and 218 are mated, the slide channel 112 is mated withthe corresponding rail 112 (FIG. 1) and barrel channel 211 so as toresist relative side-to-side movement between the pump device 100 andthe controller device 200.

As previously described, the guided motion in the longitudinal direction219 provides the user with a convenient “one-movement” process to attachthe pump device 100′ and the controller device 200. For example, theuser can readily slide the pump device 100′ and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. Thus, the infusion pump system 10 permits users to readilyjoin the pump device 100′ and the controller device 200 without compoundor otherwise difficult hand movements—a feature that can be beneficialto child users or to elderly users.

As shown in FIG. 16, when the new pump device 100′ is fully advanced andattached to the controller device 200, the gasket 140 is compressedbetween the opposing surfaces of the pump housing 110 and the controllerhousing 210. Such a configuration provides a water-resistance sealaround the electrical connection that protects the sensitive internalcomponents of the pump device 100′ and the controller device 200 fromdamage or malfunction. Although the tubing 147 of the infusion set 146is not shown in FIGS. 15-16, it should be understood that the tubing 147may be attached to the cap device 130 to provide a fluid path from thenew pump device 100′ to the user.

Accordingly, the new pump device 100′ can removably attach to thecontroller device 200 in a manner that provides a secure fitting, anoverall compact size, and a reliable electrical connection. When thepump device 100′ and the controller device 200 are arranged in thisside-by-side configuration, the controller device 200 can beelectrically connected with the pump device 100′ while the controllerdevice 200 remains outside of the pump housing 110 (and, likewise, thepump device 100 remains outside of the controller housing 210). As such,the overall size of the assembly system 10 can be minimized, therebyproviding an infusion pump system having a discrete size and enhancedportability.

Referring now to FIG. 17, the controller device 200 (shown in anexploded view) houses a number of components that can be reused with aseries of successive pump devices 100. In particular, the controllerdevice 200 includes control circuitry 240 arranged in the controllerhousing 210 that is configured to communicate control signals to thedrive system of the pump device 100. In this embodiment, the controlcircuitry 240 includes a main processor board 242 that is incommunication with a power supply board 244. The control circuitry 240includes at least one processor 243 that coordinates the electricalcommunication to and from the controller device 200 (e.g., communicationbetween the controller device 200 and the pump device 100). Theprocessor 243 can be arranged on the main processor board 242 along witha number of other electrical components such as memory devices. Itshould be understood that, although the main processor board 242 isdepicted as a printed circuit board, the main processor board can haveother forms, including multiple boards, a flexible circuit substrate,and other configurations that permit the processor 243 to operate. Thecontrol circuitry 240 can be programmable in that the user may provideone or more instructions to adjust a number of settings for theoperation of the infusion pump system 10. Such settings may be stored inthe memory devices arranged in the control circuitry 240. Furthermore,the control circuitry 240 may include one or more dedicated memorydevices that store executable software instructions for the processor243. The control circuitry 240 may include other components, such assensors, that are electrically connected to the main processor board242. For example, at least a portion of the occlusion sensor 250 (notshown in FIG. 17) can be electrically connected to the main processorboard 242 via a flexible circuit substrate or one or more wires, asdescribed in more detail below in connection with FIG. 26.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218(FIGS. 4-5) so that the control circuitry 240 can communicate controlsignals to the pump device 100 and receive feedback signals fromcomponents housed in the pump device 100. In this embodiment, theelectrical connector 118 (FIG. 5) on the pump device 100 is a z-axisconnector, and the connector 218 (FIG. 4) on the controller device 200is adapted to mate therewith. The electrical connector 218 on thecontroller device 200 is in communication with the control circuitry240. As such, the processor 243 can operate according to softwareinstructions stored in the memory device so as to send control signalsto the pump device 100 via the connector 218.

Also as previously described, the controller device 200 can include theillumination instrument 230 that may be operated by the controllercircuitry 240. For example, the illumination instrument 230 can includean LED device 232 that is electrically activated by the controlcircuitry 240 according to the user's input or according to thepreviously described automated conditions. The light emitted from theLED device 232 can be transmitted through a light guide 234 arranged onthe external face of the controller housing 210. It should be understoodthat, in other embodiments, the illumination instrument 230 may includeother light source configurations.

Still referring to FIG. 17, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes a display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of settings or menu options for theinfusion pump system 10. In this embodiment, the control circuitry 240may receive the input commands from the user's button selections andthereby cause the display device 222 to output a number of menus orprogram screens that show particular settings and data (e.g., reviewdata that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining the cartridge 120, or the like). Aspreviously described, the controller circuit 240 can be programmable inthat the input commands from the button selections can cause thecontroller circuit 240 to change any one of a number of settings for theinfusion pump system 100.

Some embodiments of the control circuitry 240 may include a cableconnector (e.g., a USB connection port or another data cable port) thatis accessible on an external portion of the controller housing 210. Assuch, a cable may be connected to the control circuitry 240 to uploaddata or program settings to the controller circuit or to download datafrom the control circuitry 240. For example, historical data of medicinedelivery can be downloaded from the control circuitry 240 (via the cableconnector) to a computer system of a physician or a user for purposes ofanalysis and program adjustments. Optionally, the data cable may alsoprovide recharging power.

Still referring to FIG. 17, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 that can receiveelectrical energy from a first power source 345 (FIG. 18) housed in thepump device 100. In this embodiment, the second power source 245 iscoupled to the power supply board 244 of the control circuitry 240. Thehard-wired transmission of the electrical energy can occur through thepreviously described connectors 118 and 218 (FIGS. 4-5). In suchcircumstances, the first power source 345 (FIG. 18) may include a highdensity battery that is capable of providing a relatively large amountof electrical energy for its package size, while the second power source245 (FIG. 17) may include a high current-output battery that is capabledischarging a brief current burst to power the drive system 105 of thepump device 100. Accordingly, the first battery 345 disposed in the pumpdevice 100 can be used to deliver electrical energy over time (e.g.,“trickle charge”) to the second battery 245 when the controller device200 is removably attached to the pump device 100. For example, aspreviously described, the first battery 345 may comprise a zinc-air cellbattery. The zinc-air cell battery 345 may have a large volumetricenergy density compared to some other battery types. For example, thezinc-air cell battery 345 may have a volumetric energy density ofgreater than about 900 Watt-hours/Liter (Wh/L), about 1000 Wh/L to about1700 Wh/L, and about 1200 Wh/L to about 1600 Wh/L. Also, the zinc-aircell battery may have a long storage life, especially in thoseembodiments in which the battery is sealed (e.g., by the removable tab141 or the like) during storage and before activation. One exemplaryzinc-air cell battery provides a potential voltage of about 1.1V toabout 1.6V (about 1.2V to about 1.4 V, and about 1.3 V in oneembodiment), a current output of about 8 mA to about 12 mA (about 10 mAin one embodiment), and a storage capacity of greater than about 600mA·h (about 650 mA·h in one embodiment).

As shown in FIG. 17, the second battery 245 may include a highcurrent-output device that is housed inside the controller housing 210.The second battery 245 can be charged over a period of time by the firstbattery 345 and then intermittently deliver high-current bursts to thedrive system 105 over a brief moment of time. For example, the secondbattery 245 may comprise a lithium-polymer battery. The lithium polymerbattery disposed in the controller device 200 may have an initialcurrent output that is greater than the zinc-air cell battery disposedin the pump device 100, but zinc-air cell battery may have an energydensity that is greater than the lithium polymer battery (e.g., thelithium polymer battery disposed in the controller device 200 may have avolumetric energy density of less than about 600 Wh/L). In addition, thelithium-polymer battery 245 is readily rechargeable, which permits thezinc-air battery 345 disposed in the pump device 100 to provideelectrical energy to the lithium-polymer battery 245 for purposes ofrecharging. One exemplary lithium-polymer battery provides a initialcurrent output of about greater than 80 mA (about 90 mA to about 110 mA,and about 100 mA in one embodiment) and a maximum potential voltage ofabout 4.0V to and 4.4V (about 4.2 V in one embodiment). In otherembodiments, it should be understood that the second power source 245may comprise a capacitor device capable of being recharged over time andintermittently discharging a current burst to activate the drive system105.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via awall-plug or other cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing or possibly eliminating the needfor separate recharging of the controller device 200 via a power cordplugged into a wall outlet.

Referring now to FIGS. 18-20, the pump device 100 may include a drivesystem 300 that is controlled by the removable controller device 200(FIGS. 1-5). Accordingly, the drive system 300 can accurately andincrementally dispense fluid from the pump device 100 in a controlledmanner. The drive system 300 may include a flexible piston rod 370 thatis incrementally advanced toward the medicine cartridge 120 so as todispense the medicine from the pump device 100. At least a portion ofthe drive system 300 is mounted, in this embodiment, to the pump housing110. In this embodiment, the pump housing 110 includes a chassis 107, ashell portion 108, and a cover mount 109. The shell portion 108 can beused to cover at least a portion of the drive system 300. For example,the shell 108 may include an inner curved surface against which a curvedsection of a piston rod 370 rests. The cover mount 109 may be assembledto the chassis 107 of the pump housing 110 to secure some components ofthe drive system 300 in position between the cover mount 109 and thechassis 107. When the cover mount 109 is assembled into place, the“unused” or retracted portion of the piston rod 370 may rest in achannel defined in the top of the cover mount 109. The shell portion 108can slide over the cover mount 109 and join with the chassis 107 to formthe assembled pump housing 110.

Some embodiments of the drive system 300 may include a battery poweredactuator (e.g., reversible motor 320 or the like) that resets a ratchetmechanism 330, a spring device 350 (FIG. 22) that provides the drivingforce to the ratchet mechanism 330, and a drive wheel 360 that isrotated by the ratchet mechanism 330 to advance the flexible piston rod370 toward the medicine cartridge 120. The operation of the drive system300 is described in more detail below in connection with FIGS. 22-25.

As shown in FIGS. 19-20, the pump device 100 can include one or moremotion detectors coupled with the drive system 300 to provide feedbackregarding the operation of the drive system 300. For example, the pumpdevice 100 may include a first motion detector 302 configured as a limitswitch that detects when a portion of the ratchet mechanism has reachedthe limit of its travel and must thereafter stop movement or reversedirection. The operation of the limit switch 302 is described in moredetail below in connection with FIGS. 22-25. In another example, thepump device 100 may include a second motion detector 307 in the form ofa mechanical error switch that indicates whether components of the drivesystem 300 completed the desired motion for each drive cycle. Theoperation of the mechanical error switch 307 is described in more detailbelow in connection with FIGS. 22-25.

Referring to FIGS. 19-20, the pump device 100 includes a connectorcircuit 310 to facilitate the transfer of signals to and from theelectrical connector 118. As previously described, the electricalconnector 118 of the pump device 100 mates with the connector 218 (FIG.4) of the controller device 200 so that electrical communication canoccur between the pump device 100 and the controller device 200. Theconnector circuit 310 may comprise a generally non-complex circuit 310that does not include a processor or other relatively high-costcomponents. In this embodiment, the connector circuit 310 operates as apassageway for the control signals (from the control circuitry 240 (FIG.17) of the controller device 200) to transmit to the drive system 300(e.g., to the actuator 320). For example, the reversible motor 320 maybe connected to the connector circuit 310 via one or more wires 304. Theconnector circuit 310 also operates as a passageway for the electricalpower from the first battery 345 (FIG. 19) to pass to the controllerdevice 200 for recharging of the second battery 245 (FIG. 17). Forexample, the first battery 345 may be connected to the connector circuit310 via one or more power contacts 305. Furthermore, the connectorcircuit 310 operates as a passageway for feedback signals (e.g., fromthe motion detectors 302 and 307) to transmit to the control circuitry240 (FIG. 17) of the controller device 200. For example, the limitswitch 302 may be connected to the connector circuit 310 via one or morewires 306 (the one or more wires connecting the mechanical error switch307 to the connector circuit 310 are not shown in FIGS. 19-20).

In some embodiments, the connector circuit 310 in the pump device 100includes a memory device 318 that can store data regarding the pumpdevice 100 and its operational history. For example, the memory device318 of the connector circuit 310 may include a flash memory chip that isconfigured to store data such as: a unique serial number designated forthe pump device 100, a manufacturer identifier code, and a drive cyclecounter. The unique serial number designated for the pump device 100 andthe manufacturer identifier code may be useful pieces of quality controlinformation that remains with the pump device 100 throughout itsshelf-life and operational life. If, for example, a manufacturing erroris identified for a particular pump device 100, the unique serial numberand the manufacturer identifier code (e.g., a lot code) can be used topromptly identify the manufacturing location and its manufacturing lot.

The drive cycle counter stored in the memory device 318 can be usefulfor maintaining an accurate estimate of the volume of medicine thatremains in the medicine cartridge 120. For example, the number of drivecycles that are required to incrementally advance the plunger 125 andthereby dispense a full medicine cartridge 120 may be a predeterminedvalue (e.g., in some embodiments, 6,300 drive cycles result in fulldispensation of a new medicine cartridge). Accordingly, the drive cyclecounter stored in the memory device 318 can keep track of the number ofdrive cycles that have occurred through the operational life of the pumpdevice 100. Each time the motor 320 completes a new drive cycle andincrementally advances the piston rod 370 to dispense some medicine, thecontroller device 200 can store an updated value for the drive cyclecounter stored in the memory device 318. When the updated value storedin drive cycle counter stored in the memory device 318 approaches thepredetermined value, the controller device 200 can alert the user thatthe medicine cartridge is approaching exhaustion. Furthermore, becausethe memory device 318 is arranged in the pump device 100, the drivecycle counter stored in the memory device 318 remains local to the pumpdevice 100. If the pump device 100 is temporarily disconnected from thecontroller device 200 and then reconnected (or reconnected to adifferent controller device 200), the controller device 200 can retrievethe value for the drive cycle counter stored in the memory device 318and promptly ascertain how much medicine remains in the medicinecartridge 120.

Still referring to FIGS. 19-20, in some embodiments, the flexible pistonrod 370 comprises a plurality of segments 372 serially connected byhinge portions 373 so that the flexible piston rod 370 is adjustablefrom a curved shape to a noncurved shape. The plurality of segments 372and the interconnecting hinge portions 373 can be integrally formed inone piece from one or more moldable materials, including polymermaterials such as Nylon or POM. In this embodiment, each of theplurality of rod segments 372 includes an exterior thread pattern 374along at least one cylindrical surface portion. The piston rod 370 alsoincludes a plunger engagement device 375 can be arranged at a forwardend of the piston rod 370. As such, the plunger engagement device 375faces toward the medicine cartridge 120 when the medicine cartridge 120is inserted into the cavity 116. In some embodiments, the plungerengagement device 375 may comprise a pusher disc that abuts against theplunger 125 of the medicine device (refer, for example, to FIG. 21).

Referring to FIG. 21, some embodiments of the piston rod 370 can beoptionally configured to attach with the medicine cartridge 120 when themedicine cartridge 120 is advanced into the cavity 116. For example,when the cap device 130 (refer to FIG. 1) is attached to the pumphousing 110 to retain the medicine cartridge 120 therein, a portion ofthe cap device 130 can push upon the body of the cartridge 120. As shownin FIG. 21, a longitudinal force 140 may be applied to the medicinecartridge 120 during engagement of the cap device 130 to the pumphousing 110. This longitudinal force 140 can be used to urge a portionof the medicine cartridge 120 (e.g., the plunger 125 in this embodiment)to secure to a plunger engagement device 375 (FIG. 21) that isoptionally included on the piston rod 370. In some embodiments, theplunger engagement device 375 may include penetration members 376 (threesuch members 376 in the example depicted in FIG. 21) that penetrate intothe plunger 125 of the medicine cartridge 120 and thereby secure themedicine cartridge 120 to the piston rod 170. (It should be understoodthat FIGS. 18-19 depicts the piston rod 370 arranged in the pump housing110 of the pump device 100, and FIG. 21 shows a similar view with thepiston rod 370 with other portions of the pump device 100 removed forpurposes of illustrating the piston rod 370 and medicine cartridge 120.)In this embodiment, the plunger engagement device 375 includes aplurality of penetration members 376 that extend from a pusher disc 378toward the plunger 125 and are configured to penetrate into the plunger125 in response to the longitudinal force 140 (FIGS. 7B and 10).Thereafter, the plunger 125 may remain secured to the piston rod 370during operation of the pump device 100, which may serve to reduce thecompliance of the plunger material and thereby increase the dosageaccuracy. Furthermore, the penetration members 376 secure the plunger125 to the drive system (e.g., to the piston rod 370 in thisembodiment), so the plunger 125 does not necessarily become displacedwhen the medicine cartridge 120 is impacted. For example, if the pumpdevice 100 is dropped on the ground and undergoes an impact, the plunger125 may be retained in its position relative to the wall of thecartridge 120 due to the attachment with the piston rod 370 via thepenetration members 376.

In some embodiments, the flexible piston rod 370 can include ananti-rotation structure that hinders the piston rod 370 from rotatingwith the drive wheel 360 (thereby allowing the rotation of the drivewheel 360 to translate into a longitudinal motion of the piston rod370). For example, as shown in FIGS. 19-21, the flexible piston 370includes longitudinal flat surfaces 371 extending along each of thesegments 372. The longitudinal flat surfaces 371 can engage acomplementary surface on the pump housing 110 (not shown in FIGS. 19-21)proximate the drive wheel 360 so that the flexible piston rod 370 ishindered from rotating when the drive wheel 360 turns. Accordingly, thelongitudinal flat surfaces 371 on each segment 372 align to form a keythat is received in a mating keyway (e.g., a complementary flat surface)on the pump housing. In other embodiments, the anti-rotation structuremay include one or more longitudinal channels (with each channel capableof engaging an associated protrusion that acts as a key to hinderrotation while permitting longitudinal motion) or the like.

Because the flexible piston rod 370 is adjustable from a curved shape toa noncurved shape, the overall length of the pump device can be reducedin some embodiments. For example, in a typical infusion pump that housesa straight and rigid rod, the typical infusion pump requires a packageor housing having a linear dimension sufficient to accommodate thelength of the rigid piston rod when it is at its limit of travel inwhich it is fully withdrawn from the container or cylinder. The pumpdevice 100 incorporating the flexible piston rod 370 can require lessspace than a similar device that houses a non-flexible, rigid rod.

Referring now in more detail to the components of the drive system 300depicted in FIGS. 22-25, the electrically powered actuator may be in theform of the motor 320 having a rotatable output shaft 321. In thisembodiment, the motor 320 is reversible in that can receive signals thatcause the output shaft 321 to rotate in a first rotational direction orin a second, opposite rotational direction. One example of a suitablemotor 320 is a coreless DC motor with reversible rotation capabilities.As previously described, the operation of the motor 320 can becontrolled by the removable controller device 200 (FIGS. 1-5) viaelectrical signals communicated through the mating electrical connectors118 and 218 (FIGS. 4-5).

Still referring to FIGS. 22-25, a gear system 322 may be coupled to themotor 320 so that actuation by the motor 320 causes a pusher arm 325 toact upon the ratchet mechanism 330 or to decouple from the ratchetmechanism 330. In this embodiment, the gear system 322 includes a wormgear 323 and a gear reduction assembly comprising spur gears 324 a, 324b, and 324 c. As described in more detail below, one of the spur gears(e.g., segmented gear 324 c) may engage the limit switch 302 when itreaches the opposite ends of its reciprocating motion, therebyindicating that the motor 320 should reverse its rotational direction orstop rotating.

The pusher arm 325 can be pivotably coupled to the gear 324 c so thatpartial rotation of the gear 324 c causes the pusher arm to reciprocatewithin a guide slot 328. The guide slot 328 can be formed in the body ofthe chassis 307 (FIGS. 18-20) of the pump housing. The pusher arm 325can have a slider pin 326 that fits into the guide slot 328 arereciprocates therein.

Accordingly, rotation of the motor 320 in a first direction can betranslated into an advancement force to the pusher arm 325. Theadvancement force on the pusher arm 325 is applied to a pawl member 335,which (in this embodiment) causes the pawl member 335 to pivot to areset position (refer to FIG. 29). In addition, rotation of the motor320 in a second direction can be translated into an retraction force tothe pusher arm 325, which can cause the pusher arm 325 to be separatedfrom the pawl member 335 during the drive step (refer to FIG. 25). Assuch, the motor 320, the gear system 322, and the pusher arm 325 cancollectively operate as an actuator assembly that provides a reliableand consistent adjustment of the ratchet mechanism 330 during a resetstep (refer to FIG. 24). Moreover, this actuator assembly (e.g., themotor 320, the gear system 322, and the pusher arm 325) can be activatedto separate from the pawl member 335, thereby permitting the motor 320to decouple from the ratchet mechanism 330 during a drive step (refer toFIG. 25).

Referring to FIG. 22, the motion path of the pusher arm 325 can beconfigured to provide an efficient mechanical advantage orientationduring the desired motion of the adjustable pawl member 335. In thisembodiment, the pusher arm 325 is directed by the guide slot 328 formedin an interior surface of the pump housing 110. In this embodiment, thepusher arm 325 includes the slider pin 326 that is received within theguide slot 328 during assembly of the pump device 100. The portion ofthe pusher arm 325 proximate the slider pin 326 can abut against thepawl member 335 when the pusher arm 325 is advanced. As such, when afirst end of the pusher arm 325 is moved by the gear 324 c, a second endof the pusher arm (proximate the slider pin 326) is directed by theguide slot 328. The orientation of the pusher arm 325 relative to theguide slot 328 can be configured to provide an efficient mechanicaladvantage for the pushing force applied by the pusher arm 325 during thedesired motion of the adjustable pawl member 335.

Still referring to FIG. 22, the ratchet mechanism 330 includes the pawlmember 335 and a ratchet body 340, which in this embodiment is a ratchetwheel having a number of teeth along its circumferential surface. Inthis embodiment, the ratchet wheel 340 is coupled with a worm gear 344,and incremental rotation of the ratchet wheel 340 causes rotation of adrive wheel 360 (due to engagement with the worm gear 344). The pawlmember 335 is adjustable between a reset position (refer to FIG. 24) anda forward position (refer to FIG. 25). For example, during the resetstep, the motor 320 may be activated to advance the pusher arm 325(guided by the guide slot 328), and the pusher arm 325 then applies apushing force that adjusts the pawl member 335 to the reset position inwhich the pawl member 335 grabs a new tooth of the ratchet wheel 340(refer to FIG. 24). In this embodiment, the adjustable pawl member 335is pivotably coupled to about the axis of rotation for the ratchet wheel340 and the worm gear 344.

A spring device 350 is also coupled to the pawl member 335 so as to urgethe pawl member 335 toward the forward position (refer to FIG. 25). Inthis embodiment, the spring device 350 is in the form of a coil springthat is fixed to the pump housing 110 (not shown in FIGS. 22-25) at afirst end portion 352 and that is engaged with the pawl member 335 at asecond end portion 354. Thus, as shown in FIG. 24, when the pawl member335 is adjusted to the reset position, the spring device 350 is intension and stores potential energy that urges the pawl member 335 toreturn to the forward position (refer to FIG. 25) and thereby drive theratchet wheel 340 in a forward rotational direction.

In some embodiments, a locking pawl 342 can be used to prevent theratchet wheel 340 from reverse motion. The locking pawl 342 can flex orotherwise adjust to permit the incremental forward rotation of theratchet wheel 340. As such, the adjustable pawl member 335 can adjustfrom the forward position (refer to FIG. 28) to the reset position(refer to FIG. 29) to engage a new tooth of the ratchet wheel 340 whilethe ratchet wheel 340 remains in position due to the locking pawl 342.

Still referring to FIG. 22, in some embodiments the ratchet wheel 340can be integrally formed with the worm gear 344 so that the incrementalrotation of the ratchet wheel 340 is translated to the worm gear 344.Such rotation of the worm gear 344 causes rotation of the drive wheel360. The drive wheel 360 includes a central aperture having an internalthread pattern therein (not shown in FIG. 22), which mates is anexternal thread pattern 374 on the rod segments 372. Thus, theincremental motion provided by the ratchet mechanism 330, the pusher arm325, and the motor 320 causes the drive wheel 360 to incrementallyrotate, which in turn translates to a longitudinal advancement of theflexible piston rod 370.

Accordingly, in these embodiments, the piston rod 370 may undergo onlyforward or positive longitudinal displacement as a result of drivesystem 300. For example, the drive system 300 substantially hinders thepiston rod 370 from retracting or “backing up” in response to fluidpressure in the medicine cartridge 120 or other reversal forces. In suchcircumstances, the flexible piston rod 370 can be retracted only uponmanual disassembly of the pump device 100 (e.g., to disengage the drivegear 360 or the ratchet mechanism 330). In those embodiments in whichthe pump device 100 is intended to be disposable and non-reusable, thenon-retractable piston rod configuration may facilitate a “one time use”disposable pump device by hinder attempts to insert a new medicinecartridge 120 in a previously used pump device 100. Such a configurationcan thereby reducing the likelihood of failure due to non-intendedrepeated use of the disposable pump device 100.

In the embodiment depicted in FIGS. 22-23, the pump device includes atleast two motion detectors 302 and 307. As previously described, thefirst motion detector 302 may comprise a limit switch that is activatedwhen the segmented gear 324 c of the gear system 320 reaches the ends ofits reciprocating travel path. For example, as shown in FIG. 23, thelimit switch 302 may include a middle arm 303 a that is arranged betweentwo lateral arms 303 b-c. When the motor 320 rotates and causes thesegmented gear 324 c to rotate in a first direction along its travelpath, the middle arm 303 a of the limit switch 302 engages a first wallof the segmented gear 324 when the gear 324 reaches the end of itstravel path. This causes the middle arm 303 a to flex and therebycontact one of the lateral arms 303 b, which signals to the controllerdevice 200 that the gear 324 c (and the rotational motor 320) reachedthe end of its travel path. Thereafter, the controller device 200signals the motor 320 to reverse its rotation, which causes thesegmented gear to reciprocate back toward the opposite end of its travelpath. When the segmented gear 324 c reaches the opposite end of itstravel path, the middle arm 303 a of the limit switch 302 engages asecond wall of the segmented gear 324. This causes the middle arm 303 ato flex and thereby contact the opposite lateral arm 303 c, whichsignals to the controller device 200 that the gear 324 c (and therotational motor 320) reached the opposite end of its travel path.Thereafter, the controller device 200 signals the motor 320 to ceaserotation until a later time when a new drive cycle is signaled.

As previously described, the second motion detector 307 may comprise amechanical error switch that is activated when the worm gear 344 isincrementally rotated with each drive cycle. For example, as shown inFIG. 23, mechanical error switch 307 may include a first arm 3083 a thatis arranged adjacent to a second arm 308 b. The first arm 308 a has alonger length so that is can be engaged by the threads of the worm gear344. Accordingly, when the drive system 300 operates to incrementallyrotate the worm gear 344, the first arm 308 a is temporarily flexed intocontact with the second arm 308 b. This temporary contact signals to thecontroller device 200 that the ratchet mechanism 330 and spring 350successfully translated the drive energy to rotate the worm gear 344(which rotates the drive gear 360 and thereby advances the piston rod370).

Accordingly, the pump device 100 can include one or more motiondetectors coupled with the drive system 300 to provide feedbackregarding the operation of the drive system 300. It should be understoodthat, in other embodiments, these detectors can be optical, magnetic, orother contact-type sensors. The detectors can be capable of transmittingsignals that indicate when components of the drive system 300 (e.g., oneof the gears in the gear system 322, the pusher arm 325, or the pawlmember 335) has completed a particular motion. Such detector signals maybe transmitted to the motor 330, to the controller device 200 (FIGS.1-5), or a combination thereof.

Referring now to FIGS. 24-25, the incremental motion cycle of the drivesystem 300 may include rotation of the motor 320 so that the pusher arm325 is advanced from a first position to act upon the pawl member 335and then retracted back to the first position. Such movement of thepusher arm 325 can cause the pawl member 335 to adjust from the forwardposition, to the reset position (refer to FIG. 24), and back to theforward position (refer to FIG. 25) under the driving force of thespring device 350. The adjustment of the pawl member 352 from the resetposition to the forward position drives the ratchet wheel 340 and wormgear 344, which incrementally rotates the drive wheel 360 and therebyadvances the flexible piston rod 370 a longitudinal increment distance.In one example, the drive system 300 can advance the piston rod 370 alongitudinal increment distance of about 16 microns or less (about 4microns to about 12 microns, about 5 microns to about 9 microns, andpreferably about 6 microns to about 8 microns) for each incrementalmotion cycle of the ratchet mechanism 330.

In this embodiment of the incremental motion cycle, the pawl member 335begins with the pusher arm 325 retracted in a first position (e.g., therest position in this embodiment). The adjustable pawl member 335 can bein this forward position, for example, because the drive system 300previously completed a drive step at an earlier time.

Referring to FIG. 24, in response to the controller device transmittinga signal to initiate the cycle, the motor 320 may begin to rotate in afirst rotational direction that advances the pusher arm 325 to pushagainst the pawl member 335. Such movement of the pusher arm 325 causesa pushing force 327 that overcomes the bias of the spring device 350 andadjusts the pawl member 335 toward the reset position (e.g., the resetstep). When the adjustable pawl member 335 reaches the reset position,as shown in FIG. 24, the pawl member 335 is capable of engaging a newtooth of the ratchet wheel 340. The locking pawl 342 prevents theratchet wheel 340 from rotating in a reverse (non-forward) rotationaldirection while the adjustable pawl member 335 is shifting back to thereset position. Such an adjustment of the pawl member 335 back to thereset position creates a tension force 357 in the spring device 350 (asshown in FIG. 24), thereby storing potential energy to drive theadjustable pawl member 335 and ratchet wheel 340 in a forward rotationaldirection for the drive step.

Referring to FIG. 25, after the pawl member 335 reaches the resetposition, the motor 330 stops rotating in the first rotational directionand reverses to rotate in the second, opposite rotational direction.Such rotation in the second direction by the motor 320 causes the pusherarm 325 to promptly retract to the first position (while guided by theguide slot 328). As such, the spring device 350 begins to urge the pawlmember 335 toward the forward position. When the adjustable pawl 335 isdriving the ratchet wheel 340 in the forward rotational direction, thepotential energy of the spring device 350 is being translated to kineticenergy for the motion of the pawl member 335 and the ratchet wheel 340.Such an adjustment of the pawl member 335 from the reset position to theforward position drives the ratchet wheel 340 and the integrally formedworm gear 344. The incremental rotation of the worm gear 344 results inan incremental rotation by the drive wheel 360, which advances theflexible piston rod 370 a longitudinal increment distance. Such anincremental advancement of the flexible piston rod 370 can cause apredetermined volume of fluid to be dispensed from the cartridge 120. Inthe event of a subsequent cycle (including the reset step and the drivestep), the motor 320 would begin by rotating in the first rotationaldirection so as to advance the pusher arm 325 yet again. This pattern ofcycles may continue until the piston rod 370 has reached the limit ofits longitudinal travel.

Still referring to FIG. 25, although the pusher arm 325 can be promptlyretracted to the first position due to the reverse rotation of the motor320, the pawl member 335 is driven to the forward position (refer to themotion 329 in FIG. 25) over a greater period of time. This period oftime required for the drive step is affected by a number of factors,including the spring force from the spring device 350, the fluidpressure inside the medicine cartridge 120, and the like. Accordingly,the pusher arm 325 can be temporarily separated from the pawl member 335when it is retracted to its first position, thereby causing the motor320 to be decoupled from the ratchet mechanism 330 during the drivestep. For example, the portion of the pusher arm 325 proximate theslider pin 326 can become temporarily spaced apart by a distance 329from the pawl member 335 while the pawl member 335 is being driven fromthe reset position (FIG. 29) to the forward position (FIG. 28). Such aconfiguration permits the motor 320 to expend a short burst ofelectrical energy to reset the ratchet mechanism 330 (e.g., duringadvancement of the pusher arm 325) while contributing no energy duringthe drive step to drive the ratchet mechanism 330 to the forwardposition for dispensation of medicine. Because the motor 320 can bedecoupled from the ratchet mechanism 330 during the drive step, only thespring device 350 expends energy over a period of time to drive theratchet mechanism 330 to the forward position. Accordingly, the pumpdevice 100 can reliably and accurately dispense dosages of medicine in asafe and energy efficient manner. In particular, the motor 320 is notrequired to draw energy from the battery over an extended period of time(e.g., during the drive step in which the piston rod 370 is advanced todispense medicine over a period of time). Instead, the motor 320 maydraw upon the battery power during advancement of the pusher arm 325 toquickly reset the ratchet mechanism 330 and during the brief retractionof the pusher arm 325.

Moreover, the reversible rotation of the motor 320 may provide enhancedsafety. As previously described, each drive cycle (including the resetstep and the drive step) includes rotation of the motor 320 in a firstdirection and subsequent rotation in a second opposite direction. Thus,in certain embodiments, if a short-circuit or other malfunction of themotor 320 causes continuous rotation of the motor 320 in one direction,such a malfunction does not result in continuous dispensation (e.g., apossible over dosage) of medicine to the user. Accordingly, the drivesystem 300 can be reliably operated to dispense the selected dosages ofmedicine.

Referring now to FIGS. 26-33, the infusion pump system 10 can beequipped with an occlusion sensor that detects occlusions in the fluidflow path extending to the user. For example, the controller device 200may include an optical sensor system 250 that detects the amount oflight reflected from a portion of the cap device 130. In thisembodiment, the optical sensor system 250 can detect changes in theamount of light reflected from the cap device 130 in response to anocclusion that causes an increase in the fluid pressure. For example, asdescribed below in connection with FIGS. 32-33, the optical sensorsystem 250 may operate using the principle of total internal reflection.

Referring to FIG. 26, although the optical sensor system 250 operates todetect changes in the flow path from the pump device 100 (e.g., throughthe cap device 130), the optical sensor system 250 may include a numberof components that are housed in the controller device 200. For example,a light emitter and light sensor may be arranged on a sensor circuit 252that is housed by the controller device 200, thereby permitting thesecomponents to be reused along with the controller device (while therelatively low cost components in the pump device 100 are discardedafter the “one time use” of the pump device 100). The sensor circuit 252can be arranged so that the cap device 130 is aligned with the lightemitter and the light sensor (described below) when the pump device 100is attached to the controller device 200. It should be understood thatthe pump housing 110 and the controller housing 210 have been removedfrom FIG. 26 for purposes of showing the relative position of the sensorcircuit 252 (in the controller device 200 as shown in FIGS. 4-5) and thecap device 130 (attached to the pump housing 110 as shown in FIG. 4-5).

The sensor circuit 252 can be connected to the control circuitry 240 ofthe controller device 200 (FIG. 17) via a flexible circuit substrate orone or more wires. In this embodiment, the sensor circuit 252 connectswith the main processor board 242 via a flexible circuit substrate. Assuch, the control circuitry 240 can receive sensor signals and employdetection software stored in one or more memory devices to determine ifan occlusion exists. If the sensor signals from optical sensor system250 indicate that an occlusion exists in the fluid flow path, thecontroller device 200 can trigger an alert to inform the user. The alertmay include a visual or audible alarm communicated via the userinterface 220 of the controller device 200.

Referring to FIG. 27, the cap device 130 can have a multi-piececonstruction that provides a flow path from the medicine container 120to the output port 139 (and to the infusion set tubing 147). At least aportion of the flow path through the cap device 130 may be monitored bythe optical sensor system 250 to determine if an occlusion existsdownstream of the cap device 130 (e.g., if a kink or clog exists in theinfusion set tubing 147 of cannula 149). The multi-piece construction ofthe cap device 130 can facilitate proper alignment of the cap device 130and proper engagement with the medicine cartridge 120 during attachmentof the cap device 130 to the pump housing 110. For example, the capdevice 130 may include a first component 136 that is movably engagedwith a second component 137. During attachment of the cap device 130 tothe pump housing, the first component 136 can be rotated relative to thesecond component 137, which causes the second component 137 to advancelongitudinally toward the medicine cartridge 120. In such circumstances,a needle penetrator 133 attached to the second component 137 can beadvanced toward the septum 121 of the medicine cartridge 120 to piercethe septum and open a fluid flow path. The flow path for the medicinethat is dispensed from the medicine cartridge 120 can pass through theneedle penetrator 133, through a fluid channel 260 (described below),through the infusion set tubing 147, and to the user.

The fluid channel 260 arranged in the cap device 130 may be at leastpartially defined by a flexible member 264. For example, in thisembodiment, one side of the fluid channel 260 is defined by the flexiblemembrane 264 so that the channel 260 through which the medicine travelsincludes a portion that is flexible. An air cavity 265 is disposedadjacent to the flexible membrane 264 opposite to the fluid channel 260,thus providing a volume into which the flexible membrane 264 can expandas pressure rises in the fluid channel 260. The flexible membrane 264may comprise a flexible polymer material that bulges or otherwisedeforms as the fluid pressure in the flow channel 260 rises. As such,the flexible membrane 264 can flex into the air cavity 265 when thefluid pressure rises due to an occlusion in the flow path downstream ofthe fluid channel 260.

Referring now to FIGS. 28-29, the sensor circuit 252 can be arranged sothat fluid channel 260 in the cap device 130 is aligned with the lightemitter 253 and the light sensor 258 when the pump device 100 isattached to the controller device 200. Thus, when the infusion pumpsystem 10 is operating to dispense medicine, the light emitter 253 inthe controller device 200 can direct light toward the fluid channel 260in the cap device 130, and the light sensor 258 can receive lightreflected from portions of the cap device 130. A cross-section throughthe cap device 130 and the controller device 200 (refer to FIGS. 28-29)illustrates one example of the alignment. It should be understood fromthe description herein that other alignment configurations can beimplemented so that the light sensor 258 in the reusable controllerdevice 200 is able to detect changes to fluid flow conditions in thepump device 100.

In this embodiment, the sensor circuit 252 is arranged to at leastpartially extend to the barrel channel 211 (FIGS. 4-5) of the controllerdevice 200 so that the light emitter 253 and the light sensor 258 arepositioned adjacent to the cap device 130. As previously described, thetabs 132 of the cap device 130 can be positioned in a manner thatfacilitates the particular orientation of the cap device 130 relative tothe sensor circuit 252. The light from the light emitter 253 can passthrough one or more portions of the cap device 130 during its traveltoward the fluid channel 260, flexible membrane 264, and air cavity 265.Accordingly, some portions of the cap device 130 may comprise agenerally transparent material to permit light transmissiontherethrough. In this embodiment, the first component 136 of the capdevice 130 can include a generally transparent polymer material. Also,in some embodiments, some portions of the cap device 130 may includewindows or openings to avoid interfering with the light from the lightemitter 253. For example, the second component 137 may includes openingsat selected locations so that light from the light emitter 253 can passby the second component 137 and to the internal light transmissivemember 254.

Still referring to FIGS. 28-29, the internal light transmissive member254 can be configured to receive light from the light emitter 253,transmit at least a portion of that light toward the fluid channel 260.In this embodiment, the internal light transmissive member 254 comprisesa generally transparent polymer material that is capable of lighttransmission. As described in more detail below, the light that istransmitted in the transmission member 254 toward the fluid channel 260can (in some circumstances) reflect from the interface where theinternal light transmissive member 254 meets the air cavity 265. Thisreflected light can be further transmitted through the internal lighttransmissive member 254 to the light sensor 258.

Referring now to FIGS. 30-31, the optical sensor system 250 can be usedto detect when an occlusion exists in the flow path from the pump device100 to the user. For example, when an occlusion occurs in the infusionset tubing 147 (FIGS. 6-7), the delivery of medicine from the infusionpump system 10 to the user can be stopped or otherwise limited. If theuser is unaware of the occlusion, the user may be deprived of theintended dosages of medicine from the infusion pump device for a periodof time. Accordingly, the optical sensor system 250 can be used todetect when such occlusions occur in the flow path to the user, and thecontroller device 200 can thereafter alert the user of the occlusionwhen particular conditions are met. The user may then inspect the pumpdevice 100 or the infusion set 146 to eliminate the occlusion.

As shown in FIG. 30, when no substantial occlusion exists in the flowpath, the medicine can be dispensed under normal operating conditionsfrom the medicine cartridge 120, through the cap device 130, and intothe infusion tubing 147. In these normal operating conditions, the fluidpressure of the medicine passing through the cap device 130 may be belowa selected threshold value. As such, the flexible membrane 264 that isadjacent to the fluid channel 260 is not substantially deformed (e.g.,the membrane 264 does not flex downwardly into the air cavity 265 toabut the internal light transmissive member 254). In thesecircumstances, the light from the light emitter 253 can be reflected atthe interface where the internal light transmissive member 254 meets theair cavity 265. In some embodiments, this light reflection may occur dueto total internal reflection that the interface. Total internalreflection can occur in some circumstances when light passes through afirst medium (e.g., the internal light transmissive member 254) andstrikes an interface between the first medium and a second medium (e.g.,the air cavity 265) at an angle greater than the critical angle. If therefractive index of the second medium (e.g., the air cavity 265) islower than refractive index of the first medium (e.g., the internallight transmissive member 254), the light may undergo total internalreflection within the first medium.

For example, as shown in FIG. 30, the light emitter 253 can be aninfrared light emitted that is directed toward the internal lighttransmissive member 254. The infrared light passes through the generallytransparent first component 136 of the cap device 130 and then strikes acurved surface 255 of the internal light transmissive member 254. Theinfrared light may be refracted at the interface with the internal lighttransmissive member 254. The curved surface 255 may operate as afocusing lens that directs the infrared light toward the air cavity 265proximate to the fluid channel 260. When the medicine is dispensed undernormal operating conditions, the flexible membrane 264 does not flexdownwardly into the air cavity 265 to abut the internal lighttransmissive member 254. Accordingly, the infrared light passing throughthe internal light transmissive member 254 reflects at the interfacewhere the internal light transmissive member 254 meets the air cavity265. This reflected light continues through the internal lighttransmissive member 254 toward a second curved surface 257. The secondcurved surface 255 may operate as a focusing lens that directs theinfrared light toward the light sensor 258. The light sensor 258 maycomprise an infrared photo detector that is capable of converting thereceipt of infrared light into electrical signals. These electricalsignals from the light sensor 258 can be transmitted via the sensorcircuit 252 to the control circuitry 240 (FIGS. 17 and 26) forprocessing to determine if an occlusion alarm should be provided to theuser.

As shown in FIG. 31, when an occlusion exists in the flow path, thefluid pressure of the medicine passing through the cap device 130 mayrise to a level above the threshold value. For example, if pump device100 attempts to dispense another incremental dosage medicine when theinfusion set tubing 147 is clogged or kinked, the fluid pressureupstream of the occlusion (e.g., in the medicine cartridge 120 and inthe cap device 130) may be increased. In these circumstances, theflexible membrane 264 that is adjacent to the fluid channel 260 may besubstantially deformed (e.g., the membrane 264 will flex downwardly intothe air cavity 265 to abut the internal light transmissive member 254.)

The interface where the internal light transmissive member 254 meets theflexible membrane 264 (FIG. 31) provides different optical results thanthe previously described interface where the internal light transmissivemember 254 meets the air cavity (FIG. 30). In particular, the amount oflight from the light emitter 253 that is internally reflected at theinterface where the internal light transmissive member 254 meets theflexible membrane 264 is measurably less (as illustrated by the dottedlines in FIG. 31). For example, none of the light or some other reducedportion of light from the light emitter 253 is internally reflected.(The light that is not internally reflected at this interface may passinto the medium of flexible membrane 264 as illustrated, for example, inFIG. 33.) If any portion of the light is internally reflected, thisreduced portion of reflected light continues through the internal lighttransmissive member 254 toward a second curved surface 257 and thentoward the light sensor 258. As previously, the light sensor 258 maycomprise an infrared photo detector that is capable of converting thereceipt of infrared light into electrical signals. Because amount oflight that is internally reflected in the light transmissive member 254is measurably less, the light sensor 258 can produce detection signalsthat are different from those described in connection with FIG. 30.These detection signals may indicate that the fluid pressure in the capdevice 130 has risen above a threshold level due to a downstreamocclusion. Again, these detection signals from the light sensor 258 canbe transmitted via the sensor circuit 252 to the control circuitry 240(FIGS. 17 and 26) for processing to determine if an occlusion alarmshould be provided to the user.

Referring to FIGS. 32-33, the process of determining whether anocclusion exists can be implemented using the control circuitry 240 ofthe controller device 200. In particular, the control circuitry 240 canbe used to activate the light emitter 253 and the light sensor 258 atselected times to monitor the fluid pressure in the flow path. Forexample, the control circuitry 240 can activate the light emitter 253and the light sensor 258 one or more times before the drive system 300(FIGS. 18-20) is activated to force medicine from the medicine cartridge120, while the drive system 300 is activated, or after the drive system300 is activated. The control circuitry 240 can receive detector signalsfrom the light sensor 258 and thereafter process the data to determineif an alarm should be triggered to notify the user of an occlusion.

Referring to FIG. 32, in this embodiment, the control circuitry 240 canactivate the sensor circuit 252 one or more times shortly before thedrive system 300 (FIGS. 18-20) is activated to force medicine from themedicine cartridge 120. When the sensor circuit 252 is activated, thelight emitter 253 emits light toward the internal light transmissivemember 254. The light from the light emitter 253 can be in the form ofan infrared light beam. As shown in FIG. 32, when no substantialocclusion exists in the flow path, the fluid pressure of the medicinepassing through the cap device 130 may be below a selected thresholdvalue. In these circumstances, the flexible membrane 264 that isadjacent to the fluid channel 260 is not substantially deformed (e.g.,the membrane 264 does not flex downwardly into the air cavity 265 toabut the internal light transmissive member 254). As previouslydescribed in connection with FIG. 30, the light from the light emitter253 can be reflected at the interface where the internal lighttransmissive member 254 meets the air cavity 265. In some embodiments,this light reflection may occur due to total internal reflection at theinterface. This reflected light continues through the internal lighttransmissive member 254 toward a second curved surface 257. The secondcurved surface 255 may operate as a focusing lens that directs theinfrared light toward the light sensor 258. As previously described, insome embodiments, the light sensor 258 may comprise an infrared photodetector that is capable of converting the receipt of infrared lightinto electrical signals. These electrical signals from the light sensor258 can be transmitted via the sensor circuit 252 to the controlcircuitry 240. The control circuitry 240 receives the signals from thelight sensor 258 and uses this data to determine if an occlusion alarmshould be provided to the user. In this example depicted in FIG. 32, thecontrol circuitry 240 receives signals that indicate the pressure in thefluid channel 260 is within the normal operating range, so the controlcircuitry would not trigger an alarm for the user.

Referring to FIG. 33, again, the control circuitry 240 can activate thesensor circuit 252 one or more times shortly before the drive system 300(FIGS. 18-20) is activated to force medicine from the medicine cartridge120. When the sensor circuit 252 is activated, the light emitter 253emits light toward the light transmissive member 254. When an occlusionexists in the flow path, the fluid pressure of the medicine passingthrough the cap device 130 may rise to a level above the thresholdvalue. For example, when one or more earlier drive cycles were attemptedwhile the infusion set tubing 147 is clogged or kinked, the fluidpressure upstream of the occlusion (e.g., in the medicine cartridge 120and in the cap device 130) can be increased. In these circumstances, theflexible membrane 264 that is adjacent to the fluid channel 260 may besubstantially deformed (e.g., the membrane 264 will flex downwardly intothe air cavity 265 to abut the light transmissive member 254.) Aspreviously described in connection with FIG. 31, the interface where thelight transmissive member 254 meets the flexible membrane 264 (FIGS. 31and 33) provides different optical results than the previously describedinterface where the light transmissive member 254 meets the air cavity(FIGS. 30 and 32). In particular, the amount of light from the lightemitter 253 that is internally reflected at the interface where thelight transmissive member 254 meets the flexible membrane 264 ismeasurably less (as illustrated by the dotted lines in FIG. 33).

As shown in FIG. 33, the light that is not internally reflected at thisinterface may pass into the medium of flexible membrane 264 and perhapsinto the fluid channel 260. For example, the refractive index of thematerial of the flexible membrane 264 can be substantially similar tothat of the material of the light transmissive member 254. As a result,the light being transmitted through the light transmissive member 254can pass into the flexible membrane 264 when the membrane 264 flexesinto the air cavity 265 and contacts the flat surface of the lighttransmissive member 254. The light from the light emitter 253 does notundergo total internal reflection at the portion where the flexiblemembrane 264 interfaces with light transmissive member 254, therebyresulting in reduced amount of light received by the light sensor 258.If any portion of the light is internally reflected, this reducedportion of reflected light continues through the light transmissivemember 254 toward a second curved surface 257 and then toward the lightsensor 258. Because the amount of light that is internally reflected inthe light transmissive member 254 is measurably less, the light sensor258 can produce detection signals that are different from thosedescribed in connection with FIG. 32. These detection signals from thelight sensor 258 can be transmitted via the sensor circuit 252 to thecontrol circuitry 240. The control circuitry 240 receives the signalsfrom the light sensor 258 and uses this data to determine if anocclusion alarm should be provided to the user. In this example depictedin FIG. 33, these detection signals may indicate that the fluid pressurein the cap device 130 has risen above the threshold level due to adownstream occlusion.

As previously described, the control circuitry 240 receives the signalsfrom the light sensor 258 and uses this data to determine if anocclusion alarm should be provided to the user. For example, the controlcircuitry 240 may include a detection software module and an alarmtrigger module stored in one or more memory devices (e.g., on the mainprocessor board 242).

The detection software module may include instructions to use the datasignals from the light sensor 258 as input data for a comparativealgorithm that determines if an occlusion exists. The comparativealgorithm can, for example, compare the data values from the lightsensor 258 to an initial value recorded when the pump device 100 wasinitially activated with no occlusions in the flow path. Alternatively,the comparative algorithm can, for example, average the data values fromthe light sensor 258 recorded over a predetermined period of time (e.g.,2 minutes, 5 minutes, 10 minutes, 30 minutes, or the like) or over apredetermined number of pump drive cycles (e.g., the last 3 drivecycles, the last 5 drive cycles, the last 10 drive cycles). Then, thisaverage value can be compare to an initial value recorded when the pumpdevice 100 was initially activated with no occlusions in the flow path.These comparative algorithms can be used to reduce the instances of“false alarms” that are provided to the user, and in some cases, can beused to reduce error created by noise in the sensor system. It should beunderstood from the description herein that, in other embodiments, thedetection software module may employ other algorithms to process thedata and thereby determine if an occlusion exists.

If the detection software module indicates than an occlusion exists, thecontrol circuitry 240 can activate the alarm trigger module to alert theuser. The alarm trigger module can be used to activate the userinterface 220 (FIGS. 1-2) to communicate one or more alarms. Forexample, the alarm trigger module of the control circuitry may be usedto activate an audible alarm, a visual alarm (e.g., on the displaydevice 222 (FIGS. 1-2)), or a combination thereof. In some embodiments,the alarm trigger module is configured to provide a set of escalatingalarms. For example, the first stage of the alarm may include a lowintensity audible alert followed by a textual alarm on the displaydevice. If the user does not respond after a predetermined period oftime (e.g., 10 seconds, 30 seconds, or the like), the alarm triggermodule may then provide a high intensity audible alert (e.g., louderalert) in combination with a visual alarm having image effects on thedisplay device (e.g., a blinking screen, alternating images, or thelike). The alarm trigger module may include further stages of alarm ifthe user does not respond after a predetermined period of time. When theuser is alerted to the occlusion in the flow path, the user can inspectthe infusion set tubing 147 and the cannula 149 to determine if there isa repairable kink. If the occlusion is substantial, the user can suspendthe operation of the infusion pump system 10 and replace the infusionset 146 with a new infusion set 146.

Referring to FIGS. 34-38, some embodiments of the occlusion sensorsystem 250 may operate to detect changes in the pressure of the fluideven though the flexible membrane is not positioned against the medicineflow path. For example, in this embodiment, the flexible membrane 264′is not positioned against the medicine flow path through the fluidchannel 260′ of the cap device 130. Instead, the flexible member 264′ isarranged near a terminal end of a capillary tube 261′ that offshootsfrom the fluid channel 260′. The capillary tube 261′ may have anorientation and size such that a pocket of air is trapped in thecapillary tube 261′ as the medicine flows through the fluid channel 260′and to the infusion set tubing 147 (e.g., during an initial primingoperation or the like). Accordingly, the infusion pump system 10 canoperate to dispense the medicine from the cartridge 120 and through thefluid channel 260′ without the requirement that the medicine contactsthe material of the membrane 264′ (described in more detail below inconnection with FIGS. 35-36). Furthermore, the capillary tube 261′enables the flexible membrane 264′ and air cavity 265′ to be arranged ina greater range of positions that are offset from the centrally locatedfluid channel 260′, which can provide a greater angle of incidence forthe reflected light within the light transmissive member 254 (describedin more detail below in connection with FIGS. 37-38).

Similar to the previous embodiments described in connection with FIG.27, the cap device 130 has a multi-piece construction that provides aflow path from the medicine container 120, through the fluid channel260′, and to the output port 139 (and then to the infusion set tubing147). The pressure of the medicine passing through the cap device 130may be monitored by the optical sensor system 250 to determine if anocclusion exists downstream of the cap device 130 (e.g., if a kink orclog exists in the infusion set tubing 147 of cannula 149). Similar tothe previous embodiments described in connection with FIG. 27, the capdevice 130 may include a first component 136 that is movably engagedwith a second component 137. During attachment of the cap device 130 tothe pump housing, the first component 136 can be rotated relative to thesecond component 137, which causes the second component 137 to advancelongitudinally toward the medicine cartridge 120. In such circumstances,the needle penetrator 133 attached to the second component 137 can beadvanced toward the septum 121 of the medicine cartridge 120 to piercethe septum and open a fluid flow path. The flow path for the medicinethat is dispensed from the medicine cartridge 120 can pass through theneedle penetrator 133, through the fluid channel 260′, and then to theinfusion set tubing 147 for delivery to the user.

As shown in FIG. 34, the fluid channel 260′ arranged in the cap device130 is defined by one or more rigid side walls, and the capillary tube261′ may extend in a transverse direction from the fluid channel 260′.The capillary tube 261′ may have an orientation and size such that themedicine forced through the fluid channel 260′ (e.g., during an initialpriming operation or the like) does not completely fill the capillarytube 261′, but instead traps a pocket of air in the capillary tube 261′as the medicine flows through the channel 260′ and to the infusion settubing 147 (refer, for example, to FIGS. 35-36). The flexible membrane264′ is positioned against a terminal end of the capillary tube 261′ sothat the air trapped in the capillary tube 261′ can apply a pressure tothe membrane 264′. An air cavity 265′ is disposed adjacent to theflexible membrane 264′ opposite to the pocket of air in the capillarytube 261′, thus providing a volume into which the flexible membrane 264′can expand as the pressure is applied to the flexible membrane 264′.Similar to previously described embodiments, the flexible membrane 264may comprise a flexible polymer material that bulges or otherwisedeforms as the air pressure in the capillary tube 261′ rises (inresponse to a rise in the fluid pressure in the flow channel 260′). Assuch, the flexible membrane 264′ can flex into the air cavity 265′ whenthe fluid pressure rises due to an occlusion in the flow path downstreamof the fluid channel 260′.

Referring now to FIGS. 35-36 (which show a closer view of the capillarytube 261′ and flexible membrane 264′ from FIG. 34), a pocket of air 127can be trapped in the capillary tube 261′ to separate the flexiblemembrane 264′ from the flow of medicine 126 through the fluid channel260′. For example, before the medicine 126 is initially dispensedthrough the fluid channel 260′ and to the infusion set tubing 147 (FIG.34), the fluid channel 260′ and the capillary tube 261′ may have airtherein. When the pump device 100 (FIG. 1) is activated to dispensingmedicine 126 from the cartridge 120 (FIG. 34) (e.g., during a primingoperation or the like), the medicine 126 is delivered through the fluidchannel 260′ along the flow path to the infusion set tubing 147 (FIG.34). When the medicine 126 is forced through the fluid channel 260′, thepocket of air 127 can be trapped in the capillary tube 261′ so as toseparate the medicine 126 in the flow path from the flexible membrane264′.

As shown in FIG. 35, during normal operation, the medicine 126 can movealong the flow path through the fluid channel 260′ and to the infusionset tubing 147 (FIG. 34) for dispensation to the user. In suchcircumstances, the fluid pressure of the medicine 126 is maintainedwithin a normal operating range because the infusion set tubing 147(FIG. 34) or other part of the flow path is not kinked, clogged, orotherwise occluded. Because the fluid pressure of the medicine 126 iswithin the normal operating range, the air pocket 127 in the capillarytube 261′ is also maintained within the normal operating range. Becausethe fluid pressure of the air pocket 127 in the capillary tube 261′ isbelow a particular level, the flexible membrane 264′ that is adjacent tothe capillary tube 261′ is not substantially deformed (e.g., themembrane 264′ does not flex downwardly into the air cavity 265′ to abutthe internal light transmissive member 254). As previously described,the light from the light emitter 253 can be reflected at the interfacewhere the internal light transmissive member 254 meets the air cavity265′.

As shown in FIG. 36, when an occlusion exists in the flow path, thefluid pressure of the medicine 126 passing through the cap device 130may rise to a level above the normal operating range. For example, ifpump device 100 attempts to dispense another incremental dosage medicinewhen the infusion set tubing 147 (FIG. 34) is clogged or kinked, thefluid pressure upstream of the occlusion (e.g., in the fluid channel260′) may be increased. In these circumstances, the air pocket 127trapped in the capillary tube 261′ may be compressed due to the addedpressure from the medicine 126. The increased pressure in the air pocket127 can cause the flexible membrane 264′ to be substantially deformed(e.g., the membrane 264′ will flex downwardly into the air cavity 265′to abut the light transmissive member 254.) Even though some portion ofthe medicine 126 may advance into the capillary tube 261′, the airpocket 127 separates the flexible membrane 264′ from the flow path suchthat the flexible membrane 264′ does not contact the medicine 126.

Still referring to FIGS. 35-36, the capillary tube 261′ may have anorientation and size such that the medicine forced through the fluidchannel 260′ (e.g., during an initial priming operation or the like)does not completely fill the capillary tube 261′, thereby trapping theair pocket 127 therein. For example, in this embodiment, the capillarytube 261′ may extend generally perpendicularly from the longitudinalaxis of the fluid channel 261. Furthermore, the capillary tube 261′ mayhave a diameter at the opening that meets the fluid channel 260′ whichis substantially small than the length of the capillary tube 261′. Inone example, the capillary tube 261′ may have a length-to-diameter ratiothat is greater than about four, greater than about 6, greater thanabout 10, and preferably greater than about twelve. (Note that thecapillary tube 261′ is not necessarily illustrated in proportion in FIG.34.) Accordingly, the medicine 126 forced through the fluid channel 260′(e.g., during an initial priming operation or the like) does not advanceto the flexible membrane ′264 but instead traps the air pocket 127 inthe capillary tube 261′ as the medicine flows through the channel 260′and to the infusion set tubing 147

Referring now to FIGS. 37-38, the capillary tube 261′ enables theflexible membrane 264′ and air cavity 265′ to be arranged in a positionthat is offset from the fluid channel 260′, thereby providing a greaterangle of incidence for the reflected light within the light transmissivemember 254. For example, the embodiment depicted in FIGS. 37-38illustrates that the flexible membrane 264′ and the air cavity 265′ arearranged close to the light emitter 253 and light sensor 258 (ascompared to the embodiment depicted in FIGS. 32-33). In suchcircumstances, the light from the light emitter 253 (as directed bysurface 255) approaches the interface between the light transmissivemember 254 and the air cavity 265′ at a greater angle of incidence,thereby facilitating the phenomenon of total internal reflection (referto FIG. 37). As previously described, total internal reflection canoccur in some circumstances when light passes through a first medium(e.g., the internal light transmissive member 254) and strikes aninterface between the first medium and a second medium (e.g., the aircavity 265) at an angle of incidence greater than the critical angle. Ifthe refractive index of the second medium (e.g., the air cavity 265) islower than refractive index of the first medium (e.g., the internallight transmissive member 254), the light can undergo total internalreflection within the first medium.

Similar to embodiments previously described in connection with FIGS.32-33, the process of determining whether an occlusion exists can beimplemented using the control circuitry 240 of the controller device200. In particular, the control circuitry 240 can be used to activatethe light emitter 253 and the light sensor 258 at selected times tomonitor the fluid pressure in the flow path. The control circuitry 240can receive detector signals from the light sensor 258 and thereafterprocess the data to determine if an alarm should be triggered to notifythe user of an occlusion.

As shown in FIG. 37, when no substantial occlusion exists in the flowpath, the fluid pressure of the medicine passing through the fluidchannel 260′ may be within the normal operating range. In thesecircumstances, the flexible membrane 264′ that is adjacent to thecapillary tube 261′ is not substantially deformed (e.g., the membrane264′ does not flex downwardly into the air cavity 265′ to abut theinternal light transmissive member 254). As such, the light from thelight emitter 253 can pass through the light transmissive member 254,and then reflect at the interface where the internal light transmissivemember 254 meets the air cavity 265. This light reflection may occur dueto total internal reflection at the interface. This reflected lightcontinues through the internal light transmissive member 254 toward asecond curved surface 257, directs the light toward the light sensor258. As previously described, in some embodiments, the light sensor 258may comprise an infrared photo detector that is capable of convertingthe receipt of infrared light into electrical signals. These electricalsignals from the light sensor 258 can be transmitted via the sensorcircuit 252 to the control circuitry 240. The control circuitry 240receives the signals from the light sensor 258 and uses this data todetermine if an occlusion alarm should be provided to the user. In thisexample depicted in FIG. 37, the control circuitry 240 receives signalsthat indicate the pressure in the fluid channel 260 is within the normaloperating range, so the control circuitry would not trigger an alarm forthe user.

As shown in FIG. 38, when an occlusion exists in the flow path, thefluid pressure of the medicine passing through the cap device 130 mayrise to a level above the normal operating range. As such, the airpocket 127 (FIGS. 35-36) in the capillary tube 261′ may act upon theflexible membrane 264′ to substantially deform it (e.g., the membrane264′ will flex downwardly into the air cavity 265′ to abut the lighttransmissive member 254.) As previously described, the interface wherethe light transmissive member 254 meets the flexible membrane 264′provides different optical results than the previously describedinterface where the light transmissive member 254 meets the air cavity265′ (FIG. 37). In particular, the amount of light from the lightemitter 253 that is internally reflected at the interface where thelight transmissive member 254′ meets the flexible membrane 264′ ismeasurably less (as illustrated by the dotted lines in FIG. 38).

The light that is not internally reflected at this interface may passinto the medium of flexible membrane 264′ and perhaps into the capillarytube ′261. For example, the refractive index of the material of theflexible membrane 264′ can be substantially similar to that of thematerial of the light transmissive member 254. As a result, the lightbeing transmitted through the light transmissive member 254 can passinto the flexible membrane 264′ when the membrane 264′ flexes into theair cavity 265′ and contacts the flat surface of the light transmissivemember 254. The light from the light emitter 253 does not undergo totalinternal reflection at the portion where the flexible membrane 264′interfaces with light transmissive member 254, thereby resulting inreduced amount of light received by the light sensor 258. If any portionof the light is internally reflected, this reduced portion of reflectedlight continues through the light transmissive member 254 toward asecond curved surface 257 and then toward the light sensor 258. Becausethe amount of light that is internally reflected in the lighttransmissive member 254 is measurably less, the light sensor 258 canproduce detection signals that are different from those described inconnection with FIG. 37. These detection signals from the light sensor258 can be transmitted via the sensor circuit 252 to the controlcircuitry 240. The control circuitry 240 receives the signals from thelight sensor 258 and uses this data to determine if an occlusion alarmshould be provided to the user. For example, the control circuitry 240may include the previously described detection software module and thepreviously described alarm trigger module stored in one or more memorydevices (e.g., on the main processor board 242). In this exampledepicted in FIG. 38, the detection signals may indicate that the fluidpressure in the cap device 130 has risen above the normal operatingrange due to a downstream occlusion.

In alternative embodiments, the occlusion sensor may include a systemother than the optical sensor system 250 described in connection withFIGS. 26-33 and 34-38. For example, the occlusion sensor may comprise aforce transducer arranged on the piston rod 370 (FIGS. 22-25) so as todetect changes in the fluid pressure in the medicine cartridge. In suchembodiments, the controller device 200 may be configured to receive thesignals from the force transducer to determine if an occlusion alarmshould be provided to the user. For example, the force transducersignals can be input to the detection software module stored in one ormore memory devices (e.g., on the main processor board 242).

In another example, the cap device 130 may house at least a portion ofan occlusion sensor that is configured to detect the flow of medicinethrough the cap device 130 or to detect an occlusion in the fluid path.Such an occlusion sensor housed at least partially in the cap device 130may include a pair of electrodes surfaces that are arranged to detectfluid flow through the cap device 130. For example, an AC current may bepassed through the fluid between the two electrodes, and the electrodescan be configured to sense the electrical admittance (e.g., the inverseof the electrical impedance) through the fluid in the bypass fluid path166. The electrical admittance sensed using the electrodes can becorrelated to a fluid velocity (e.g., a change in the flow speed causesa change in the electrical admittance). In such embodiments, thecontroller device 200 may be programmed to correlate the fluid velocityfrom the electrical admittance sensed using the electrodes.

It should be understood from the description herein that, in alternativeembodiments, other types of occlusion sensors can operate within the capdevice 130 to detect flow (or nonflow) of the medicine. For example, theocclusion sensor housed at least partially in the cap device may includea pressure sensor that indicates the fluid pressure in the cap device130. For example, a miniature pressure transducer can be arranged in thecap device 130 to detect the fluid pressure. In some cases, theminiature pressure transducer can be formed as a MEMS(Micro-ElectroMechanical System) device. The miniature pressuretransducer may be output an electrical signal that can be correlated toa fluid pressure value. In such embodiments, the controller device 200may be programmed to correlate the fluid pressure from the signal outputby the pressure transducer. In another example, the occlusion sensor mayinclude a first probe and a second probe arranged in the cap device130—the first probe being used to induce a small oxygen (O₂)concentration into the fluid flow, and the second probe being used todetect the oxygen level in the fluid flow. If the second probe detectsan oxygen concentration greater than a threshold level, the fluid flowmay be occluded or partially occluded. As such, the controller device200 may communicate an alarm to the user that an occlusion exists in thefluid path.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. A wearable infusion pump system, comprising: a disposable andnon-reusable pump device including a drive system to dispense medicinefrom the pump device, the pump device having a first electricalconnector that is externally accessible; a reusable controller deviceremovably attachable to the disposable and non-reusable pump device, thecontroller device including a second electrical connector that isengageable with the first connector to provide electrical communicationbetween control circuitry of the controller device and the drive systemof the pump device; and a water-resistant seal device arranged proximateto the first and second electrical connectors when the controller deviceis removably attached to the pump device.
 2. The pump system of claim 1,wherein the water-resistant seal device resists migration of externalcontaminants toward the first and second electrical connectors when thereusable controller device is removably attached to the non-reusablepump device.
 3. The pump system of claim 2, wherein the water-resistantseal device is compressed between the adjacent surfaces of the pumpdevice and the controller device when the controller device is removablyattached to the pump device.
 4. The pump system of claim 2, wherein thewater-resistant seal device comprises a polymer foam gasket coupled toan external surface of the non-reusable pump device.
 5. The pump systemof claim 4, wherein the polymer foam gasket surrounds an electricalinterface between the first and second electrical connectors when thecontroller device is removably attached to the pump device.
 6. The pumpsystem of claim 1, wherein the water-resistant seal device resistsmigration of water to the first and second electrical connectors whenthe pump system is submerged underwater for a particular period of time.7. The pump system of claim 6, wherein the particular period of time atleast four hours.
 8. The pump system of claim 1, wherein the first andsecond electrical connectors engage one another by a guided motion in alongitudinal direction.
 9. The pump system of claim 8, wherein thewater-resistant seal device comprises a major seal surface that extendsgenerally perpendicular to the longitudinal direction.
 10. The pumpsystem of claim 9, wherein the water-resistant seal device compressedbetween the adjacent surfaces of the pump device and the controllerdevice when the first and second electrical connectors engage oneanother by the guided motion in the longitudinal direction.
 11. A methodof connecting components of an infusion pump system, the methodcomprising: preparing a pump device for use with a controller device,the pump device including at least a portion of a drive system todispense medicine from the pump device, the controller device includingcontrol circuitry to communicate control signals to the drive system ofthe pump device; removably attaching the pump device with the controllerdevice so that a first electrical connector of the pump device engages asecond electrical connector of the controller device; and compressing awater-resistant seal device between the pump device and the controllerto resist migration of water toward the first and second electricalconnectors.
 12. The method of claim 11, wherein the water-resistant sealdevice resists migration of external contaminants toward the first andsecond electrical connectors when the controller device is removablyattached to the pump device.
 13. The method of claim 11, wherein thewater-resistant seal device comprises a polymer foam gasket coupled toan external surface of the pump device.
 14. The method of claim 13,wherein the polymer foam gasket surrounds an electrical interfacebetween the first and second electrical connectors when the controllerdevice is removably attached to the pump device.
 15. The method of claim11, further comprising exposing external surfaces of the pump device andthe removably attached controller device to one or more externalcontaminants.
 16. The method of claim 15, wherein the one or moreexternal contaminants are selected from the group consisting ofprecipitation, water splashes, sweat, and dirt.
 17. The method of claim11, wherein the water-resistant seal device resists migration of waterto the first and second electrical connectors when the pump device andthe removably attached controller device are submerged underwater for aparticular period of time.
 18. The method of claim 17, wherein theparticular period of time at least four hours.
 19. The method of claim11, further comprising activating the controller device so that thecontroller device signals the pump device to dispense the medicine. 20.The method of claim 19, further comprising detaching the pump devicefrom the controller device after the medicine in the pump device isexhausted.
 21. The method of claim 20, further comprising removablyattaching a new pump device with said controller device.
 22. Acontaminant-resistant infusion pump assembly, comprising: a pump deviceincluding: a drive system to dispense a medicine from the pump device, apump housing to enclose at least a portion of the drive system, and afirst electrical connector that is externally accessible along the pumphousing; a seal device attached to an external surface of the pumphousing proximate to the first electrical connector; and a controllerdevice removably attached to the pump device, the controller deviceincluding: a user interface having a display device and at least onebutton, control circuitry to communicate with the drive system of thepump device, a controller housing to enclose at least a portion of thecontrol circuitry, and a second electrical connector is engaged with thefirst connector to provide electrical communication between the controlcircuitry and the drive system, wherein the seal device is arrangedbetween a surface of the pump housing and an opposing surface of thecontroller housing to resist migration of external contaminants towardthe first and second electrical connectors.
 23. The pump assembly ofclaim 22, wherein the seal device is compressed between the adjacentsurfaces of the pump device and the controller device when thecontroller device is removably attached to the pump device.
 24. The pumpassembly of claim 22, wherein the seal device comprises a polymer foamgasket coupled to an external surface of the pump device.
 25. The pumpassembly of claim 24, wherein the polymer foam gasket surrounds thefirst electrical connector.
 26. The pump assembly of claim 22, whereinthe seal device resists migration of water toward the first and secondelectrical connectors when the pump assembly is submerged underwater forat least four hours.